FDA Device Recalls in 2020

Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards hemodynamic monitoring technology module and/or cable and accompanying Edwards accessories and/or disposables. It provides Edwards hemodynamic monitoring technologies through modular connections. The HemoSphere Swan-Ganz Module (HEMSG

Pre-procedural issues related to software defects

Consignees were sent recall notification letters on approximately 10/11/2017. The letter identified the affected product, problem and actions to be taken. instructions included coordination with the respective Edwards representative to schedule the software upgrade.

Microsurgical Operating Room Tables;7300B (18-350-70);

Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating signal errors of Tabletops MST 7300B and MST 7300BX.

The firm's representatives notified their U.S. consignees regarding the recall notification by phone and a separate FedEx letter was sent (08/09/2019 - date the letter was issued). The Customer Notification Letter "IMPORTANT VOLUNTARY RECALL NOTIFICATION", informed customers of the two (2) types of errors: 1) Unintended Tilting of the Tabletop - Impurities in the hydraulic oil has caused minor leaking inside a control valve causing the table to tilt after remaining static for long periods of time. 2) Incorrect Operation due to Infrared Operating Signal Errors - The table can inadvertently mix infrared signals from the hand pendant while using in the wireless mode and may cause unintended movement. Customer are also being informed that a sales representative will contact them to organize the logistics of the correction for the tables. The recall notification includes to visit the firm's webpage (www.mizuho.com) to find additional information related to the recall. For additional questions, the Customer Service Group or local sales representatives can be contacted.

BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended use: to drill into bone in hip or knee surgeries.

One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device.

Initial contact to customers was by telephone and visit on 18 October 2019. The firm followed with a letter disseminated by email on 10/25/2019. The firm is seeking return of the affected units and will replace them with correct devices.

COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S

The product is being recalled because Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S) were mislabeled as Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) and Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) were mislabeled as Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S).

The firm initiated the recall by letter in Europe on 18-December-2018 and 20-December-2018. The notices were sent in Japan today, 21-December-2018. The letter requested recall to the user level and return of the affected product.

Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303

Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.

Beginning on 12/09/2019, consignees were notified in person by an Abbott field representative. The firm is seeking return of the affected units. For questions about this issue or for replenishment contact your local Abbott Representative or Abbott Support at 1-855-478-5833 (option 1).

ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.

Samples tested using ARCHITECT Free T3 or ARCHITECT Total T3 assays may show depressed results due to a reagent carryover when testing on board with specific assays on the ARCHITECT i1000SR and i2000/i2999SR platforms.

Abbott notified customers on about 10/12/218 via "Product Correction Urgent - Immediate Action Required" letter. Letters were sent separately to customers who utilize the ARCHITECH i1000SR platform and the i2000/i2000SR platforms. Necessary actions for customers who utilize the ARCHITECH i1000SR platform included that if a separate instrument can be used, then separate the ARCHITECT Free T3 and ARCHITECT Total T3 assays from the specific assays listed in the letter (ARCHITECT TSH, ARCHITECT TUptake, ARCHITECT HIV Ag/Ab Combo, ARCHITECT Cortisol, ARCHITECT LH, ARCHITECT ProGRP, ARCHITECT rHTLVI/II, ARCHITECT Total PSA, ARCHITECT AFP, ARCHITECT Free PSA, ARCHITECT 25OH Vitamin D), by running these tests on different instruments. For those customers who cannot use a separate instrument, then they are instructed to perform the Maintenance Procedure (6445 Pipettor/WZ Probe Cleaning for i1000SR) in the i1000SR Operations on the instrument prior to performing batch testing for all ARCHITECT Free T3 or ARCHITECT Total T3 samples. Necessary actions for customers who utilize the i2000/i2000SR platforms included that if a separate instrument can be used, then separate the ARCHITECT Free T3 and ARCHITECT Total T3 assays from the ARCHITECT 25OH Vitamin D assay, by running these tests on different instruments. For those customers who cannot use a separate instrument, then perform Daily Maintenance (Operations Manual, 6041 for i2000/i2000SR) on the instrument prior to performing batch testing for all ARCHITECT Free T3 or ARCHITECT Total T3 samples. Additionally, instructions for both types of affected platforms included to review the letter with each customer site's Medical Director or Laboratory Director and follow laboratory protocol regarding the need for reviewing previously reported patient results. If the product has been forwarded to other laboratories, please inform them of the recall and provide a copy of the notification letter. Also, complete and r

Genius Knee Cemented Tibial Component Product Usage: Knee replacement component

Product mix up

On 12/10/2018 the firm sent letters to their customer informing them of the recall and asked the customers to Immediately examine your inventory and quarantine product subject to recall. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall by forwarding this letter. Please complete the attached Customer Acknowledgement Form and fax or email it to us so that we may arrange for your stock to be recovered and replacement stock, or a credit note, issued. Please complete the Customer Acknowledgement Form even if you have no stock which is subject to recall, as we require this information to reconcile this process. Please complete this action within 2 weeks of the date on this letter to ensure the correction is implemented expeditiously. This recall should be carried out to the hospital level. Your assistance is appreciated and necessary to prevent delay in surgery. For further information, please make contact via the details provided below. Signature Orthopaedics Pty Ltd sincerely regrets any inconvenience caused. Christian Wight Regulatory Affairs Manager Signature Orthopaedics Pty Ltd 7 Sirius Road Lane Cove West, NSW 2066 Australia Email: christian@signatureortho.com.au Phone: 02 9428 5181 Fax: 02 8456 6065

GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model Number: LU41692 Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole discretion of the physician.

Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM header. The correct patient information will be listed on the DICOM report image; however, the report may appear under a different patients name in the PACS.

The firm initiated their recall by letter on March 16, 2018. The notice stated: "Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM header. The correct patient information will be listed on the DICOM report image; however, the report may appear under a different patients name in the PACS. There have been no injuries reported as a result of this issue. You can continue using your system by disabling the DICOM MPPS feature as follows: 1. In enCORE, select Tools | Connectivity Options. 2. Select DICOM tab. 3. Press Configure Connections in DICOM Worklist section. 4. In the MPPS SCP Settings, clear the AE Title and the TCP/IP Address fields 5. Press OK to all. A GE Healthcare representative will contact you to arrange for the correction." For further questions, please call (608) 826-7492

PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantitative measurement of the nicotine metabolite cotinine (25 200 ng/mL) in capillary (fingerstick) or venous whole blood. The test is for professional use to determine if an individual has been exposed to nicotine.

The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.

The firm notified affected customers on January 21, 2020, via Urgent Medical Device Recall letter. The letter informed customers that the product had not received the necessary 510(k) clearance. Customers were asked to immediately segregate impacted product and hold for return to PTS Diagnostics. Distributors were asked to forward the notice and response form to all customers/users who may have received the product. All customers were asked to complete and return the attached acknowledgement form, even if they do not have affected product on hand. The firm's Customer Service team will contact customers upon receipt of the response form to arrange for return of the materials. If you have any questions regarding this recall, please contact the firm's Customer Service directly, Monday through Friday, 8AM-5PM EST, at +1 317-870-5610 or 877-870-5610 (toll-free), or via email at response@ptsdiagnostics.com.

Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes

Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.

The firm initiated the recall by letter on January 07, 2020. The "Urgent Medical Device Recall Notice", identified the removal of devices and instructed the customer to quarantine the affected products. The Notice provided the accompanying Recall Response Form to be completed and returned within 10 days of receipt to smithmedical4136@stericycle.com. The Notice details that the affected product must be returned to Stericycle for processing. The Notice instructed the distributor to notify their customers and to provide the customer a copy of the Recall Notice and Response Form. The Notice provided the contact email smithmedical4136@stericycle.com and phone number of 8669188738 for assistance.

Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)

Foley Catheter with Incorrect Retainer Cap Print

On December 13, 2017 a letter was sent to all their customers informing them of the following: Bard Medical Division (BMD), C.R Bard, Inc., would like to inform you of a potential labeling issue involving the BARD product code and lot numbers listed below. Manufacturing of these affected products began May 2017.Due to a manufacturing issue, there is a potential for catheters with the two lot numbers listed above to have the incorrect information printed on the purple retainer cap. The incorrect print specifies that the balloon should be inflated with 10mL of water. However, the correct volume to use to inflate the catheter balloon is 75cc . If the user underinflates the balloon with only 10mL of water, the expected effect of helping stop the bleeding as an adjunct to conventional hemostasis post-TURP may not happen as quickly as desired, likely leading to a marginal severity of harm. Additionally, the catheter may become dislodged from the patient. Instructions to Customer: "Examine your inventory and identify any product subject to this communication. During use, adhereto the correct inflation volume as stated in the packaging. "Product return is not required. If a unit does not meet your needs or you have any questions,please contact our customer service at 1-800-526-4455. "If you have further distributed or transferred this product, please identify the respective organizationsand notify them at once of this product communication. Your notification to these organizations maybe enhanced by including a copy of this medical device communication letter. We appreciate your cooperation and assistance in dealing with this matter and sincerely apologize for any inconvenience that may result from this action. If you have any questions please do not hesitate to contact your Bard representative.

DeRoyal Enteral Safe Feeding Tubes: a) REF 54-2450R, 5 FR x 24" Polyurethane b) REF 54-2465R, 6.5 FR x 24" Polyurethane c) REF 54-2480R, 8 FR x 24" Polyurethane d) REF 54-3680R, 8 FR x 36" Polyurethane Product Usage: Feeding tube

Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the connector has detached from the feeding tube.

The firm initiated the recall on 07/22/2019 by letter. The recall requested that the consignee examine their inventory and complete and return the Notice of Return Form. Distributors were directed to notify their customers or provide their customer list to DeRoyal for them to perform the notification. The firm is seeking return of the product. For questions contact your DeRoyal Representative, customer service at 888.938.7828, or email us at recalls@deroyal.com.

Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include Unicondylar knee replacement and/or patellofemoral knee replacement.

Communication-connection error.

A customer Notification letters and Product Correction Acknowledgement Forms will be sent to affected customers via UPS Day Air return receipt. Customers where informed that the affected products will be replaced.

TherMax Blood Warmer Unit

TherMax Blood Warmers may not be in compliance with an electrical safety standard, which requires a protective earth connection that can sustain a current of 25 amps for 10 seconds.

Baxter Healthcare notified customers on about 09/19/2019, via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were informed that specific TherMax Blood Warmers listed below may not be in compliance with an electrical safety standard, which requires a protective earth connection that can sustain a current of 25 amps for 10 seconds. The affected units may not have an adequate ground path, which could cause the units to become damaged if used with improperly grounded outlets. The damage could cause the TherMax Blood Warmer units to be nonfunctional during clinical use. Instructions included that customers could continue to safely use affected devices with a properly grounded outlet, that a local Baxter representative will contact each facility to arrange for the correction of affected devices, to complete and return the Baxter Customer Reply Form via fax to 224-270-5457 or scanning and e-mailing it to fca@baxter.com, and to notify customers if the product was further distributed. For general questions regarding this communication, contact Baxter Corporate Product Surveillance at 800-437-5176, between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday.

Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, and locking caps intended to provide internal fixation of fractures of the proximal humerus. The polyaxial screws have a range of motion of +/- 20. The screws can be simply lagged or locked to the plate with the addition of a locking cap. The plates are side specific implants.

Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left.

The firm notified their consignees by email beginning on 01/15/2019 requesting the examination of the Proximal Humerus Plates for mismarked units. Return of the units is ongoing.

Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.

Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices.

Beginning on December 9, 2019, US consignees will be notified in person by an Abbott field representative. OUS consignees will be notified by mail. The firm is seeking return of the devices.

Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180 Used in test systems to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.

The recommended hydration fluid for the 8180 Gram-Positive Blood Culture Control Panel (Inactivated Pellet), has changed from sterile 0.85% saline or sterile blood culture media to sterile DI water or pH 7.2 phosphate buffer.

Recall Letters was sent via email to all consignees regarding the correction on 12/16/2019 informing users of a new recommended hydration fluid which is reflected in labeling QC Sets and Panels: Technical Information TIB.2034 Rev G. Questions can be directed at Technical Support team at 1.320.229.7064 or techsupport@microbiologics.com . A response form is requested to be returned.

SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system's date and time setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.

This issue will be resolved by sending an Urgent Medical Device Correction letter to Medical Facility staff (Director of Clinical/Radiology, Risk Manager/Hospital Administrator, Director of Biomedical Engineering) with affected systems. This letter will inform the customer of the issue and instruct the user to ensure the displayed system date is correct. The long-term solution is to correct affected systems with updated software.

Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.

Incorrect (higher) Rated Burst Pressure information printed on label.

On December 7, 2018 the firm, BrosMed Medical, sent an "URGENT FIELD SAFETY NOTICE" dated December 7, 2018 to their consignee. The notice described the product, problem and actions to be taken. The consignee was instructed to do the following: " Please reference the Attachment 1 for the list of Hermes NC PTA Balloon Dilatation Catheter with affected catalogue numbers and lots numbers. . Immediately stop selling the device from these lots. " Transfer this notification and inform relevant distributors/hospitals/clinics to check their inventory, complete and return the Effectiveness Check form in attachment 2 to you, and return the affected unused Identified Hermes NC PTA Balloon Dilatation Catheters back to your warehouse, if any. " Please help collect the unused identified Hermes NC PTA Balloon Dilatation Catheters from relevant distributors/hospitals/clinics to your warehouse as well collect the Effectiveness Check Forms. " Review your inventory, complete the Effectiveness Check Forms in attachment 2 to BrosMed Medical and return all unused identified products including the collections in your warehouse to BrosMed Medical, if any . This action does not affect patients having successfully undergone interventional procedures using these devices. What is BrosMed Medical doing? BrosMed Medical has already implemented corrective actions to ensure ongoing product performance. BrosMed Medical will work with you to replace the return units with similar products. The appropriate regulatory agencies have been notified of this action. If you have any question, please do not hesitate to contact BrosMed Medical: E-mail: cs@brosmed.eu at Tel: +31850140 901.

Obturator (long cone), Part number 25162 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System. The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during visualization of and surgical site access to the anus, rectum and distal colon. The Flex Robotic System is intended for use in adults (e22 years of age). The Flex Colorectal Drive is intended for robot-assisted visualizatio

The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators.

On January 25, 2019, the firm issued an Urgent Voluntary Medical Device Recall notification letter to its customers. The letter informed customers of the potential for the handle of the obturator to detach with the cone remaining in the patient's rectum. Patients were asked to take the following actions: 1. Immediately check your inventory and quarantine all Obturators that you have on hand to prevent their further use. Note: An Obturator may be located in the same sterilization tray as the Flex Rectoscope. 2. Please immediately complete the attached Acknowledgement form -- even if you have no Obturators -and return the form it to Medrobotics by fax: +1-508-823-1703 or by email customerservice@medrobotics.com. 3. Ensure relevant staff members -- including clinicians, OR staff, engineers, and product returns staff -- are informed of this recall. 4. If you have supplied any Obturators to any other organization, please advise that organization of this recall and notify Med robotics of that organization's name, address, and contact person so that we may contact them immediately. Please contact Med robotics Customer Service at 1 +508-692-6104 or at customerservice@medrobotics.com if you have any questions or need additional information.

LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only.

The incorrect placement of AA batteries into certain LeadCare II Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the batteries are removed while hot.

An Urgent Medical Device Correction letter, dated January 9, 2018, was sent to customers. The letter identified the affected device and provided a description of the issue. If two of the four AA batteries are inserted incorrectly, the batteries may overheat, causing a minor burn if the user opens the battery compartment and tries to remove the hot batteries. Customers are to follow the steps outlined in the letter, including placing the enclosed label on the upper back panel of the analyzer to remind users who are changing batteries of the importance of correct placement. Proper battery placement should be provided in annual training. Customers are to complete and return the acknowledgement card. Please direct any questions to 800-275-0102 or LeadCareSupport@magellandx.com.

Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only

Reports of implantable mitral valve repair system clips unexpectedly opening and becoming nonfunctional, resulting from unintended excessive force applied during the Clip implantation. Excessive force can also result in unexpected movement of clip arms. The inability to close and remove the device has lead to surgery and additional intervention.

On 05/01/19, Urgent Medical Device Correction notices were sent to implanting physicians, via personal delivery or email, informing them that under normal use conditions, this failure will not occur. To prevent unintended force from being applied to the clip, revised instructions, including definition and related technique, for performing the steps "Establish Final Angle" and "Invert the Clip Arms" were developed and provided herein. The revised instructions will be applied to the shared XTR and NTR Clip Delivery System Instructions for Use. Unintended excessive force applied to the NTR Clip Delivery System during "Establish Final Arm Angle" can result in unexpected movement of clip arms; however, unlike XTR, the NTR Clip does not become damaged and remains functional. Adhering to the revised IFU sections for both product platforms will ensure consistency of use. Further, the firm requested that customers read the Field Safety Notice, review revised instructions for use with firm representatives, sign and return Effectiveness Check Forms, and share this information with all personnel associated with the procedure. The revised instruction steps provided in this communication will be updated in the product IFU and included in associated training. Your current inventory of product is acceptable for safe use following the revised IFU steps described above. There is no need to return any product. Customers with additional questions are encouraged to call customer service at 800-227-9902.

Medivators Endo Smartcap Endoscope Tubing. REF100145. Packaged as Contents 1, 10, 50, and found in BMP-C145. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes. Sterile EO - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.

Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.

An Urgent Medical Device Recall Notification letter was sent to customers via certified mail next day delivery on 10/09/2019. The letter identified affected product, stated reason for recall, asked for product to be quarantined and discontinue use. Customers are to return product to Medivators by obtaining a Return Material Authorization from Customer Service. A response form was asked to be returned. Questions can be directed to Customer Service at 1-800-444-4729.

SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of barbiturates in human urine at a cutoff value of 200 ng/mL The BARB assay provides a rapid screening procedure for determining the presence of barbiturates (BARB) and its metabolites in urine.

The firm has identified that cross-reactivity testing may not meet the claims indicated in the Barbiturates Reagent Chemistry Information Sheet (CIS). The presence of certain compounds in urine may result in false positive or false negative results.

On 06/12/2019, an Urgent Medical Device Recall Letter was sent to customers via first class mail and/or email informing them that the firm has identified, through study results, that cross-reactivity testing may not meet the claims indicated in the Barbiturates Chemistry Information Sheet (CIS). Customers were informed that the presence of the following compounds in urine may lead to false negative results: Barbital at a concentration of 1500 to ~1700 ng/mL; Butabarbital at a concentration of 250 to ~300 ng/mL; Butalbital at a concentration of 400 to ~500 ng/mL; Diallybarbital at a concentration of 600 to ~700 ng/mL; Pentobarbital at a concentration of 500 to ~600 ng/mL; Phenobarbital at a concentration of 800 to ~900 ng/mL; Talbutal at a concentration of 80 to ~125 ng/mL. Customers were also informed that the presence of Glutethimide in urine at a concentration of ~ 8 to 80 g/mL may lead to false positive results. Customers were instructed to discontinue use and discard all BARB reagent lots M903174 and older following their laboratory's disposal protocol. Customers were informed that negative results due to the differences between the claimed and actual cross reactivity concentrations are not clinically significant, and that per the current Chemistry Information Sheet for this product, the reporting of a positive result by this assay should be confirmed by another generally accepted nonimmunological method; therefore retrospective review of patient results is not required. Customers were requested to share this information with their laboratory staff and retain this recall notification as part of their laboratory Quality System documentation. If customers forwarded any of the affected product listed to another laboratory, they were requested to provide that laboratory a copy of Urgent Recall Notification Letter. Customers were requested to respond to Beckman Coulter within 10 days, electronically if the customer received the notification by email; or manu

Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794

The sets are configured with quick connectors that have been assembled in reverse on the arterial and venous lines, resulting in blue (venous) to red (arterial) and red (arterial) to blue (venous) connections. Due to this incorrect assembly, the sets cannot be primed from the reservoir prior to use, and the device may not function as intended.

Urgent Medical Device Recall - Removal notification letters dated 7/11/19 were sent to customers.

MEVION S250i, MEVION S250; Proton Radiation Treatment System

Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correction sent or recorded had some of the Couch Correction checkboxes turned off

Mevion issued letter (pCAR0012) on May 15, 2020 via mail or FedEx, with return receipt confirmation. Letter states reason for recall, health risk and action to take: Until a software fix is applied for this problem, the user is cautioned to carefully pay attention to the 3 indicators of Couch corrections. If they disagree with the intended moves the user may simply repeat the alignment step and the problem should clear. Required User Action When using multimodal imaging the user should always check the indicators for Couch Corrections before they are applied. This includes the Verity Couch Correction widget, the Verity dialog box the informs the user of the actions being sent to the Couch, and the In Room Monitor lower right panel that displays the moves before they are made. If these disagree with the intended moves, the user should back up a step and resend the corrections. Users must confirm positioning for every applied Couch correction that all intended moves are indicated and made.

Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product Usage: The Medtronic Vectris lead kits contain the implantable spinal cord stimulation lead, as well as additional components used for lead implant as part of a Neurostimulation system for pain therapy. A Medtronic implantable Neurostimulation system is indicated for spinal cord stimulation (SCS) systems as an aid in the management of chronic, intractable pain of the trunk and/or limbs-incl

This voluntary recall is being conducted due to the curved tip introducer needle which is included in the kit, to have a potential manufacturing defect. This could result in difficulty advancing or withdrawing the Vectris lead through the curved tip introducer needle.

Beginning 25 May 2018, Medtronic sent a letter via mail to affected customers. The notification included the customer letter, confirmation form (reply form), and a list of affected product serial numbers. The letter informed customers of the recall, and provided instructions on the identification and return of affected products. The firm expanded the recall, notifying their consignees by letter on 07/13/2018. Customers with device related questions can contact Technical Services at 1-800-707-0933 weekdays 7am-6pm CT.

FDA Dec 10, 2020

Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and interventional angiography and cardiology procedures.

The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.

On 11/18/2020 Shimadzu sent an "Urgent Medical Device Recall Notice" to all affected consignees. In addition to informing consignees about the recall the firm provided the following information. 1. Shimadzu has released a mandatory Service Bulletin on applicable products for the update of the positioner software. The update of the software and the testing of the positioner movement should be performed by your Authorized Shimadzu Service provider. 2. Your authorized Distributor has acknowledged receipt the Service Bulletin (XR-202026) and the recall Customer Letter. They have been instructed to provide you a copy of this letter so that you may understand the scope of the recall. Necessary software for this recall and instruction to complete have been sent to your Distributer and they should be scheduling time to perform the corrective actions. 3. Once the corrective work has been completed your Distributor will report to Shimadzu that the work has been completed so that we may track and inform the appropriate Regulatory Agencies of its completion. Actions to be taken by customer: A. Please check the list of systems affected by this recall. If your site is on the applicable list, please pay attention to the following points until the corrective work has been completed. . (1) This event does not occur in any position other than the Left or Right diagonal position, so please avoid using this product in diagonal positions. (2) When using the product in the Left or Right diagonal position, please use the direct memory function and encourage C-arm operation without using the lever. (3) If the C-arm starts to operate unintentionally, press the red "Stop Switch" button immediately. B. If you feel there is a problem with the c-arm movement, please discontinue use of the system and contact your local service provider. C. Please complete the Medical device Recall Return Response form and submit to drodriguez@shimadzu-usa.com D. Shimadzu

FDA Dec 10, 2020

Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used for temporary collection, transfer, and/or storage of body fluids and solid specimen samples for the purpose of laboratory testing.

Product was not irradiated; therefore, they are not sterile and do not meet product specification.

Thermo Fisher Scientific issued U"RGENT: MEDICAL DEVICE RECALL NOTIFICATION" dated 4/28/20 to First level and second level consignees via email as well as a recall notification letter sent by overnight mail on 4/29/20. Letter states reason for recall, health risk and action to take: Actions Requested: "Examine your inventory to determine if you have any of the above referenced product on-hand. If so, discontinue use immediately and quarantine all affected product. "Notify all affected users in your facility and anyone else you may have distributed or forwarded affected product for the specific lot number. "Please complete the attached Customer Response Sheet, regardless of whether you have affected product on-hand. Indicate the quantity you are returning and whether you are requesting a credit or product replacement and email to technicalsupport@thermofisher.com If you have any questions, call or email Technical Support, at: +1-800-625-4327 or technicalsupport@thermofisher.com

FDA Dec 9, 2020

AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immunoreaction test cup from the AIA-PACK reagent series.

The firm has become aware of a potential issue with the AIA-360 analyzer that could prevent the table home sensor from detecting the table home position. If the malfunction with the table home sensor occurs on the AIA-360, the sensor board may need to be replaced. If the home sensor fails to detect the home position, the AIA-360 analyzer will cease to function and will be unavailable for use. If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh has received three (3) complaints related to this issue with no serious injuries reported.

On October 5, 2018, the firm notified customers of the recall via Urgent Medical Device Recall letter. Customers were informed of the potential issue with the analyzer that could prevent the table home sensor from detecting the table home position. Customers were advised that the table home sensor board will be evaluated and replaced if needed at the next scheduled preventive maintenance visit. Actions to be taken by User: " Thoroughly review the content of this letter. " Continue to use your analyzer. A Tosoh representative will contact you to schedule your next preventive maintenance visit. o If you experience any problems, please contact Tosoh Technical Support for an expedited service visit. " Complete and return the attached Acknowledgement Form. " File this notice with your laboratory records and forward this information to others in your laboratory. If you have obtained unexpected test results, delays in test result reporting , or received any complaints of illness or adverse events associated with the use of the analyzer, please contact Tosoh Technical Support 24 hours a day, seven days a week at (800) 248-6764. Should you have any questions regarding this medical device recall, please feel free to contact Bernadette O'Connell at (800) 248-6764 or by email at bernadette.oconnell@tosoh.com. She will be available to answer any questions Monday- Friday, from 9:00 AM to 5:00 PM (PST).

FDA Dec 9, 2020

(1) VitreQ 23G BF Blunt Needles-BF23.D51 GTIN#: 8719214221126 (2) VitreQ 23G BF Brush Needles-BF23.D52 GTIN#: 8719214221140

Microscopic tears of the sterile pouch may compromise sterility

VitreQ issued Urgent Medical Device recall dated 12/16/19 letter states reason for recall, health risk and action to take: 1.Immediately examine your inventory and quarantine product from all lots subject to recall. If you have further distributed this product, please identify your customers and notify them at once of this product recall. Consider all potential users of this product in your user supply chain. You may provide a copy of this recall notification letter; 2.Complete the Attachment 1: Response Form enclosed IMMEDIATELY, as evidence of the product being returned, and we will credit your account or complete the response form even if you do not have product to return.3.Return the Attachment 1: Response Form to BVI by one of these methods: Fax 866-906-4304 or email a copy to Claims_US@bvimedical.com. If you have any specific product replacement questions you may contact Customer Service Team at: Claims_US@bvimedical.com or call 866-906-8080 from 8 A.M. to 6 P.M. EST (Monday-Friday).

FDA Dec 9, 2020

MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients

The perforated screen that divides the inside of the process water tank has a very sharp edge across the top of the Heat Exchanger leading to potential injury for servicer.

This screen would not be accessed by normal user (only servicer). Firm is notifying servicing personnel and not consumer/user level. No customer letters/communication sent. Servicer will install edge guard on effected units. Technical Service Bulletin issued to servicer.

AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.

The firm has become aware of a potential issue that may affect the mixing motor drive harness and mixing home detection sensor relay harness on your AIA-900 Analyzer. It is possible that the harnesses could rub against the Plarail chain during operation and result in premature wear. If observed, this issue will cause the following system error to be reported D.lane Mix home overrun error [4093] . If observed, this issue will cause the AIA-900 Analyzer not to function and the D.lane Mix home overrun error [4093] will be reported by the system. Replacement of the motor drive harness and mixing home detection sensor relay harness will mitigate the potential for premature wear and effectively prevent this issue from causing the system error. If the sensor relay harness fails, the AIA-900 analyzer will cease to function and will be unavailable for use. If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh is aware of two complaints associated with the unexpected wearing of the harness. There have been no user or patient injuries reported that are related to this device malfunction.

On September 28, 2018, the firm notified customers via Urgent Medical Device Recall letter. Customers were informed of the potential issue. Immediate Actions to be taken by the Customer: Thoroughly review the content of this letter. " Identify if the serial number of your analyzer is listed in this notification. o If the serial number of your analyzer is listed: 1. At the next service call or scheduled PM, whichever occurs first, a Tosoh field service engineer will verify the motor drive harness and mixing home detection sensor relay harness are bundled together and placed into a double-coated cable or repair the harness bundle as applicable. 2. Complete and return the attached Acknowledgement Form by any of the listed methods. o If the serial number of your analyzer is not listed: 1. Tosoh records indicate that the harness bundle on your instrument(s) has already been replaced. Complete and return the attached Acknowledgement Form by any of the listed methods. " File this notice with your laboratory records and forward this information to other supervisors or managers in your laboratory to ensure that they are aware of the potential issue.

Fetal Spiral Electrode, Model No. 9898 031 37631

During use of the Philips FSE, it is possible for the metal electrode tip to break off and remain in the scalp of the newborn following labor and delivery.

On January 25, 2019, the firm distributed Customer Information Medical Device Correction letters to affected customers. The letter informed customers that there was an increase in complaints regarding the Fetal Spiral Electrode tip breaking off, preventing easy removal from the scalp of the newborn infant. Customers were advised to do the following: * Visually examine the FSE upon removal from the newborn scalp to verify the tip is intact. If it is not intact, appropriate measures to locate and remove the missing part should be taken. * Upon receipt of this notice, clinicians should review the following information from the device's Instructions for Use: - Do not pull the Spiral Tip from the fetal skin. Do not pull the FSE wires apart. - Do not over-rotate Spiral Tip during attachment. - Inspect the Spiral Tip to ensure that it is still attached to the FSE Hub. If the tip has separated from the hub and remains embedded in the presenting part, remove it using aseptic technique. Customers were provided with a reply form and asked to complete the form and return it to Philips: 1-877-499-7223 (eFax) or email to recall.response@philips.com. If you need any further information or support concerning this issue, please contact your local Philips representative: 1-800-722-9377, option 2.

VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of a variety of analytes of clinical interest

Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to erroneous assay results being reported

Ortho Clinical Diagnostics issued on 20 March 2019, a customer letter via FedEx overnight courier and/ or ORTHO PLUS e-Communications and and/or US Postal Service Priority Mail (for PO Boxes only) customers who were shipped affected VITROS XT 7600 Systems. Software Version 3.4.2 (MOD 4) will be provided for download or DVD format. Contact Ortho Care" Technical Solutions Center at 1-800-421-3311.

BD Microtainer Tube w/ BD Microgard Closure, K2EDTA additive, Model Numbers 365974 and 365975 Product Usage: The Microtainer Brand Tube with EDTA(K2) Reorder No. 365974, is used to collect, anticoagulate, transport and store skin puncture blood specimens for testing the following hematological parameters: WBC, RBC ,HGB, HCT, MCV, MCH, MCHC, Platelets, 5 part differential including : Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Manual WBC Differentials, Reticulocytes, and Spun He

The products have been confirmed to have reduced or no additive within the tube reservoir. The tubes may develop visible clots within the tube samples or micro clots that are not easily detected during visual inspection of the tubes. A clotted sample may lead to recollection of samples or, retesting of patients, resulting in delayed reporting of test results and patient treatment.

Urgent Medical Device Recall notification letters dated 6/3/19 were sent to customers. Thee letter identified the affected product, problem and actions to be taken.

FDA Dec 7, 2020

VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents, and VITROS Immunodiagnostic Products Reagents

One of the software algorithms used to detect sample dispense errors was inadvertently disabled. Because of this, sample dispense errors may lead to incorrect results being reported without an error code to alert the user.

Urgent Product Correction Notification letters dated 3/11/19 were sent to customers.

FDA Dec 7, 2020

Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient through a needle or catheter inserted into the patient's artery or vein. These model codes are extension sets that can be used with IV administration sets. The set s components are commonly found on intravascular administration sets and extension sets. It includes a microbore tubing, a slide clamp, male and female luer.

Reports of incorrect priming volume due to manufacturing with incorrect tubing.

The firm, BD, sent an "URGENT: Medical Device Recall Notification" letter dated November 2017 to all their customers. The letter described the product, problem and actions to be taken. The customers were instructed to: immediately Discontinue use of the Alaris Extension Sets model 20022 lot numbers 16087775 and 16127995, and model number 30914 lot number 16127518. Contact BD for a replacement lot.; return the product for replacement using the following instructions; and immediately complete and return to BD the enclosed, pre-addressed and postage paid, Recall Response Card to: BD Support Center,10020 Pacific Mesa Blvd, San Diego CA 92121, by FAX: 1-858-617-4851 or by EMAIL: SupportCenter@bd.com. Note on the card your distributors name and quantities that will be returned. " Once BD receives the Recall Response Card, the BD Support Center will provide instructions for return of the affected lot numbers and replacement of the affected lots. " " All recalled product should be returned directly to the distributor from whom it was purchased. Customers will receive their return goods processed through their distributor if the products were purchased through a distributor. " " Your distributor has already been notified of this recall. If you have any questions, please contact your distributor directly, or call the BD Support Center at the number listed below." A second letter was sent on May 2018 adding an additional lot # for Alaris Extension Set with microbore tubing Model number 30914 lot number 17097167 Recall Related Questions BD Support Center Phone: 1-888-562-6018 Hours: 7am to 4pm PST, Monday -Friday Email: SupportCenter@carefusion.com

FDA Dec 4, 2020

Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.

There is a potential that the adjustable handle option on the X-Ray system may have been installed with improper bolts. This could result in improper driving operation which could lead to harm of individuals around the device.

Shimadzu issued a "Urgent: Voluntary Medical Device Recall Notice" on 11/09/2020" via email. In addition to informing consignees about the recalled device, the notification letter asked consignees to take the following actions: 1. If your unit is on the affected list, then please check the drive handle assembly to see if the bolts have loosened. If you feel there is a problem with the mobile drive and movement, please discontinue use of the system and contact your local service provider. 2. Shimadzu has identified the affected units and informed your authorized service representative. They will be contacting you to schedule time to implement the corrective action. If you do not receive a call or visit concerning this matter, please contact Shimadzu National Support. 3. Please complete the "Medical Device Recall Return Response" form and email to drodriguez@shimadzu-usa.com 4. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

FDA Dec 4, 2020

Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 11832215 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.

Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any reports of patient harm.

Cardinal Health URGENT MEDICAL DEVICE RECALL EVENT #: 2019-02623 letter dated January 15, 2020. Customers were advised that this recall is being conducted of product labeled as NON-STERILR Not For Human Use (Exhibit A). Action required includes the following: 1.CHECK all storage and usage locations to confirm whether you have any units of the affected product codes and lot numbers containing the labeling outlined in Exhibit A in your possession. Exhibit A outlines examples of product labeling and how to identify the affected product. 2.SEGREGATE and QUARANTINE all on-hand product that is confirmed to be labeled per Exhibit A. 3.PLEASE RETURN the enclosed acknowledgment form via facsimile (847-689-9101 or 614-652-9648) or email (GMB FieldCorrectiveAction@cardinalhealth.com) and indicate the product code, lot and quantity of product youve quarantined or discarded. Please respond regardless of whether or not you have affected product. 4.NOTIFY any customers to whom you may have distributed, or forwarded product affected by this recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. 5.CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product Monday Friday between 8:00am - 5:00pm EST: " Hospital800-964-5227 " Federal Government800-444-1166 " Distributor800-635-6021 " All other Customers888-444-5440 6.Customers that did not receive product directly from Cardinal Health should return product through the location where they purchased it.

FDA Dec 4, 2020

Flexible Intubation Fiberscope, Model # 11301AB1

The action is being initiated due to intubation scopes improperly manufactured with a double port luer instead of a single port luer.

The firm mailed a "safety alert" on April 24, 2019 via FedEx. 2nd day delivery. The safety alert advised customers to do the following: 1. If you use the following automated processes, the high level disinfection/liquid chemical sterilization of the flexible endoscope cannot be guaranteed: Reprocessing Method Impact, Medivators AER * Patient Safety may be Compromised, STERIS System 1E (SS1E)** Patient Safety may be Compromised The above connectors can only connect onto one port, therefore leaving the other port open. Depending on the reprocessing system, the cycle could result in an error or in successful completion of the cycle. " If an error code is displayed, the user would know the cycle is not complete and the scope has not been successfully reprocessed. " If the cycle is completed without an error code, the high-level disinfection/liquid chemical sterilization of the flexible endoscope cannot be guaranteed. Improper reprocessing may result in incomplete decontamination, which may result in a cross-contamination patient infection. If you use Medivators AER or STERIS SS1E to reprocess this scope, please be aware of the possible risks and take the necessary actions to address any patient safety concerns. 2. Please complete the attached Action Requested form and follow the instructions outlined on the form. 3. you have any questions please contact the following person: This Recall Action, Emily Cuadros, Complaint Handling , 424-218-8289 Reprocessing, Shaun McGinley, Director of Reprocessing, 424-218-8247 Patient Safety, Dr. Dennis Fowler, Chief Medical Officer, 424-218-8603

TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.

Device was shipped without a Unique Device Identification (UDI) label.

On September 26, 2019 the firm distributed Urgent Medical Device Recall Communication letters. Check the Serial Number on your TLC-2000 Power Pack (Model Number: TLC-2002) to see if your TLC-2000 is affected by the following issues: 1) The TLC-2000 Power Pack was shipped with a label identifying it as being CE compliant. What Should You Do?: No action required. The TLC-2000 is approved for sale in Canada under Medical Device License Number: 98357. The TLC-2000 is cleared for sale in the United States by the FDA under 510(k) number: K151816. *Product with Serial Number 3204 was sold in the European Union. Only the owner of Serial Number 3204 should return their TLC-2000. 2)The TLC-2000 was shipped without a Unique Device Identification (UDI) label. What Should You Do?: Please courier your TLC-2000 to Theralase, at your cost, for update. A UDI label will be added to your TLC-2000, at no charge and your TLC-2000 will be couriered back to you at Theralase's cost.

TLC-2000 Therapeutic Medical Laser System

Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard

Email was sent out to healthcare practitioners regarding the recall on September 26, 2019. Healthcare practitioners are instructed to courier their TLC-2000 to Theralase. The TLC-2000 will be updated to reduce EMI to meet IEC 60601-1-2 standard (4th edition).

TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.

Power supply (Model Number: TLC-2003) ME90A2403F01 (24 VDC, 3.75 A, 90 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 4th edition specification) shipped versus Power supply (Model Number: TLC-2003) MENB1100A2403F01 (24 VDC, 4.2 A, 101 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 3rd edition specification)

Email was sent out to healthcare practitioners regarding the recall on September 26, 2019. Healthcare practitioners are instructed to courier their TLC-2000 to Theralase. A Field Inspection Test will be completed and once passed, a Special Inspections for Medical Electrical Equipment and Systems label will be applied to the TLC-2000.The Field Inspection Test will be completed according to either CSA 60601-1 or UL 60601-1 dependent upon the customers Canadian or United States location, respectively.

TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002

Power Pack (component) was shipped with an internal battery pack tested to UN-38.3, UL-2054 and IEC-62133 (2nd Edition) standards; however, not tested to IEC-60601-1-2 (3rd edition) standards

Email was sent out to healthcare practitioners regarding the recall on September 26, 2019. Please courier your TLC-2000 to Theralase, at your cost, for modification. A Field Inspection Test will be completed and once passed, a Special Inspections for Medical Electrical Equipment and Systems label will be applied to your TLC-2000 Power Pack..

TLC-2000 Therapeutic Medical Laser System

660 nm laser diodes may be below rated power output.

Email was sent out to healthcare practitioners regarding the recall on September 26, 2019. Healthcare practitioners are instructed to courier their TLC-2000 to Theralase for analysis. Their 660 nm laser diodes will be analyzed and recalibrated / replaced, as required, to meet rated power output.

Dimension Lipase Flex Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)

Calibration failure - confirmed a positive bias with LIPL lot FB8109 when compared to other Dimension LIPL lots. Lot FB8109 is not meeting Siemens internal specifications for lot-to-lot limits.

Customers are instructed to: - Discontinue use of Dimension LIPL Assay lot FB8109. - Recalibrate with an alternate lot of Dimension LIPL Assay. - Review their inventory of this lot to determine their laboratoryfs no-charge replacement needs. - Review the UMDR/UFSN letter with their Medical Director. - Complete and return the Field Correction Effectiveness Check Form attached to the UMDR/UFSN letter within 30 days. - If they have received any complaints of illness or adverse events associated with lot FB8109, immediately contact their local Siemens Customer Care Center or their local Siemens Technical Support Representative