2021 Product Recalls

RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778

The scanner is not confirming the integrity of read barcode data using the check-digit when reading Code 39 barcodes.

On May 27, 2020, the firm notified customers via Urgent Field Safety Notice letters. Product was distributed to foreign customers only. Customers were instructed to complete and return the included customer response form. Customers whose systems are not configured to use code 39 with check-digit need take no further action. However, for customers whose systems are configured to use code 39 with check-digit, the customer notice provided two workaround options: 1) Use the integrated on-board barcode scanner, or 2) Re-configure the handheld barcode scanner following the instructions in the letter. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative

MediCult Vitrification Cooling Media, Model Number 12284001F

There is a discrepancy between the printing on the Product Tyvek label of the individual component packaging. The Chinese characters on the label indicates that it contains an Equilibration Medium (P/N: 12220001) rather than the Vitrification Medium (P/N: 12230001) as indicated on the remainder of the label.

URGENT: MEDICAL DEVICE FIELD SAFETY NOTICE letters dated 9/8/20 were sent to customers. Our records indicate that you have purchased the affected Product from CooperSurgical. The affected Vitrification Medium Product is of the correct formulation and functionally acceptable per quality release specifications and will work as intended in accordance with the accompanying Instructions For Use. Please discontinue use of and quarantine the Products, complete the attached Acknowledgement and Receipt Form, and return it to CooperSurgical. Once we receive the Acknowledgement Form, we will arrange for Product replacements and returns of affected Product. The replacement Products will be charged at the same price as the original order and your account will be credited back once the affected Products are returned to CooperSurgical. If you do not have affected Product in inventory, please use the same enclosed Form to indicate that and return it to CooperSurgical so that we may document receipt of this Field Safety Notice. The Chinese Food and Drug Administration has been notified of this Field Safety Notice. We sincerely apologize for any inconvenience caused by this Field Safety Notice. CooperSurgical is committed to high quality, safe and effective products. Please feel free to reach us at +001.203.601.5200 ext. 3300.

SMARTABLATE RF System Generator

Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.

All new U.S. and OUS customers, who have purchased the SMARTABLATE" Generator system since the launch of the original field action in March 2015 to the time the IFU was updated in November 2015, will be notified. The previously distributed Field Safety Notification Letter for the SMARTABLATE" Generator (Part Numbers# M490006 and M490007) and customer Acknowledgement Form will be sent to these new customers. Instructions included review the Field Safety Notice carefully, provide the notice to appropriate personnel in facility, ensure the SMARTABLATE System Foot Pedal is not located within the Stereotaxis RMT Lab, complete and return the Acknowledgement Forms, and maintain awareness of the notice.

Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno

When the user changes frame rates from lower frequency (e.g. 10 f/s) to higher frequency (e.g. 30 f/s) during continuous release of Fluoro "Fluoro Override", the measured Air Kerma Rate can exceed the regulatory limits.

Siemens Medical Solutions USA, Inc. has initiated a Customer Advisory Notice to all affected customers via AX067/20/P on November 30, 2020. All modifications and repairs are provided to affected customers free of charge.

CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software Uploader versions: 3.1.5.000 3.1.2.000

Incomplete basal rate information may be transmitted leading to a potential for inappropriate change in therapy. During data upload, radio frequency (RF) interference can occur at any point from surrounding devices or equipment that may affect the data transfer between the insulin pump and the CareLink Personal or CareLink System Software.

On 11/19/2020, the firm sent an "URGENT FIELD SAFETY NOTIFICATION" Letter via email, fax, mail and/or phone to its U.S. Customer, and on 12/07/2020, the firm initiated O.U.S Notification using approved regional methods. The Notification Letter informs customers that after the release of an updated uploader software version the following issues/scenarios may result: 1. Some reports may be missing all programmed basal rates in the device. This may result in a blank value on the Device Settings report of the 24-hour basal total. 2. Some reports may only display certain programmed basal rates and some basal rates in the device may be missing from the reports. This may result in a miscalculation on the Device Settings report of the 24-hour basal total. The following reports may be affected by these issues include: Device Settings, Daily Review/Daily Details, Weekly Review, and Sensor & Meter Overview. These reports have been utilized to adjust therapy settings or to transfer settings from an old pump to a new pump. If all of the following are true, it could lead to either over- or under-delivery of insulin which may result in low blood glucose (hypoglycemia, loss of consciousness), and/or high blood glucose (hyperglycemia): a) adjustments were made to therapy settings or if therapy settings were transferred from one device to another, and b) these actions were taken based on a report generated using CareLink" uploader version 3.1.5.000 that has missing or incomplete basal rates, and c) you are using Manual Mode The Recalling Firm is instructing customers to: 1. Install the new CareLink" uploader version 3.1.6.000 available within the CareLink" software to each computer where you upload devices. To confirm your current uploader version or to learn how to install the latest uploader, see the FAQ section at the end of this letter. 2. If you have had insulin settings adjusted that may have been made based on an impacted CareLink" report, review your settings

ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting.

With regards to ShapeMatch Cutting Guides using MRI Imaging, Stryker Orthopaedics has become aware that there are potential issues associated with internal processes for planning cases and producing ShapeMatch Cutting Guides.

Stryker sent Product Correction Bulletins on 11/8/2012 dated 11/9/2012 and 11/19/2012 to all affected customers. Stryker sent an updated Urgent Medical Device Product Notification letters and Acknowledgement letters dated 1/24/2013 through 1/28/2013 to all affected customers via Fed Ex with return receipt: The letter identified the affect product, problem, potential hazards, risk mitigating factors and actions to be taken. For questions call 201-831-6878. Stryker issued press release on 4/10/2013.

Philips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device.

When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or more electrical contacts could break due to pulling, twisting, or dropping of the connector. If this happens, live parts may be exposed (230 V) and/or the video signal can be lost.

On April 10, 2020, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed of the product issue. Customers were asked to do the following: - Ensure that Cabling Check and Connectors Check are performed daily, as indicated in the User Routine Checks Program (section 7.4 of the Instructions for Use provided with the system). - In case the strain relief is lost and/or damage to the cable/connector is identified; stop using the system and contact your Philips local representative so that the cable can be replaced. - Please ensure that all staff working with the system are informed of the content of this safety notice and place a copy of it with the Instructions for Use. Philips will be replacing the Stand MVS Trolley Cable (459800943703) in all affected systems by a new Stand MVS Trolley Cable that has an improved strain relief design. This action will start by end of April 2020. You will be contacted by a local Philips representative to schedule an appointment to replace the cable. If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377

D-Ring Installed Too Close To Mounting Flange

The improper crimping may result in partial or complete loss of effectiveness of the seat belt harness, increasing the risk of injury to the occupant in that seated position, in the event of a crash.

Braun will notify owners and dealers will inspect both seat belt anchor points and if no defect exists, no further action will be required. If the inspection shows the defect exists on one or both seat belt anchor points, your dealer will replace the defective insert(s) with nut plate(s) during the inspection, free of charge. The recall began on March 1, 2021. Owners may contact Braun Ambulances customer service at 1-877-344-9990.

Lift Gate License Plate Light Alignment

A license plate light aimed toward other drivers may increase the risk of a crash.

Marion will notify the owner, and a dealers will provide a replacement kit, free of charge. The recall began January 11, 2021. Owners may contact Marion customer service at 1-715-754-5261. Marion's number for this recall is 20E-034.

SRS Control Unit Can Detach

A detached SRS control unit can decrease the performance of occupant protection systems such as air bags, seat belts, and high voltage battery disconnect, increasing the risk of injury during a crash.

Volvo Car will notify owners, and dealers will inspect and, as necessary, tighten the SRS control unit mounting screws, free of charge. The recall began February 12, 2021. Owners may contact Volvo Car customer service at 1-888-458-1552. Volvo Car's number for this recall is R10068.

Warning Triangle Insufficiently Visible/FMVSS 125

The warning triangles may not be sufficiently visible to oncoming vehicles, potentially increasing the risk of a crash.

Automann will notify its distributors offering a credit for the full purchase price for all returned or destroyed units in its inventory. Automann will request that distributors notify all purchasers, for them to return the warning triangle kits, for a credit of the full purchase price. The recall began January 18, 2021. Owners may contact Automann customer service at 1-201-529-4996. Automann's number for this recall is 0012021.

Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon Pumps (IABPs), Part Number 0012-00-1589-03

One lot of "Low Level Output Cable - Interface to Philips Monitor" was received from the supplier with an incorrect cable in the packaging.

On October 3, 2019, the firm notified customers of the recall via an Urgent Medical Device Recall letter. The letter alerted customers that the incorrect cable may have been supplied. Customers were asked to take the following actions: -Please examine your inventory immediately, remove and quarantine any affected product. - If you have unused affected product, please contact Getinge Customer Service at 1-888-627-8383 (press option 2, then option 1) between the hours of 8 AM and 6 PM Eastern Standard Time to request a material authorization number (RMA) and shipping instructions. Pack the product to be returned with the appropriate return documents and, using the shipping instructions provided, arrange for pickup with the designated delivery service provider. Replacement product or a credit will be issued for your return. -Please enter the quantity and RMA number provided by Customer Service in the spaces provided on the URGENT MEDICAL DEVICE RECALL REMOVAL Response Form on Page 4 of the letter, if you are returning products to Datascope/Getinge. -Please complete and sign the attached URGENT MEDICAL DEVICE RECALL REMOVAL RESPONSE FORM (page 4) to acknowledge that you have received the notification. Return the completed form to Datascope/Getinge by emailing a scanned copy to marylou.insinga@getinge.com or by faxing the form to 1-973-807-9290. If you have any questions, please contact your Datascope/Getinge representative or call the Datascope/Getinge Customer Service at 1-888-627-8383 (press option 2, then option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).

Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox Rheumatoid Factor Latex-Enhanced Immunorutbidimetric Test Kit is an in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human serum. This test kit may be used to facilitate the detection and diagnosis of Rheumatoid Arthritis. RF have also been observed in the serum of patients with systemic lupus eruthematosus, hepatitis. Liver cirrhosis and syphil

The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to re-align to the reference material.

1. Review your reagent inventory and replace the value sheet with the new values provided. 2. Review results generated with the affected batches in line with the clinical profile of the patient. 3. Discuss the contents of this notice with your Medical Director. 4. Complete and return the response form 12187-QA to teclhnical.services@randox.com within five working days.

CapsoCAM Plus, UDI: 00867770000209

Capsule Endoscopy System: a defect present in the capsule window may be stressed through the production process and in the final package, which could cause the housing of the capsule to crack and leak when ingested. Fluid from the patient could leak in to the capsule, which may damage components inside the capsule and the patient data may not be retrieved; the patient may need to repeat the exam.

Starting on 10/18/19, Urgent Medical Device Voluntary Recall Letters were emailed to customers. Customers were asked return affected product and to complete the Return Material Authorization form. The recalling firm asked distributors to provide their latest shipment lists.

DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN Catalog Numbers CCD-A1006RX CCD-A1013EN CCD-A1015EN DCF-A2310EN DCF-A2310RX DCF-A2313EN DCF-C2310CA DCF-C2310EN DCF-E2310CA DCF-E2310EN UDI 00815098020201, 00815098020225, 00815098020232 Product Usage: Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unresponsive, not breathing or not breathing normally.

A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range.

The firm contacted affected customers via email and mailed letter on April 27, 2020. Distributors were asked to forward letters to end users. Customers were informed that affected products may abort a shock delivery or reset unexpectedly. Customers were asked to return all affected products for screening. Actions to be taken by the Customer/User: 1. If you have additional AEDs on hand , please quarantine and return any affected units as identified in the Attachment for screening or replacement. Do not include the pads and battery packs when you return your unit. 2. If no other AEDs are available, please continue using the device with caution until a loaner or replacement is provided. 3. Ensure that all users of the AED are informed of the product issue. Defibtech will provide support for handling all aspects of the return of identified units for screening. The firm will contact customers to help them with the process. If you have questions now, please contact the firm using the email address FA2020@defibtech.com. Additionally, Defibtech Customer Support is available by calling 1-877-453-4507, 8:30 A.M. to 5:30 P.M. (Eastern), Monday - Friday.

3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.

Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert.

The firm, DJO Global, sent an "URGENT FIELD SAFETY NOTICE" dated 5/31/2017 by email to its consignees on 5/31/2017. The notice described the product, problem and actions to be taken. The consignees were instructed to do the following actions by June 16, 2017: pass notice on to all those within the organization or to any organization where the affected product has been transferred; contact customer service at 1-800-456-8696 to place a replacement order and obtain shipment information; return all affected devices; and complete, sign and return the Acknowledgment and Receipt Form by email to: Desiree.Wells@djoglobal.com. The Regulatory Affairs department will follow-up via phone and email with non-responding consignees. If you have any questions, please contact Sr. Director Regulatory Affairs by phone at (760) 734-3551 or by email at Neeta.Sharma@djoglobal.com.

Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.

Software issue related to the StealthStation S7 system and the Synergy Spine application Version 2.1 configured with Spine Tool Install CD version 25. Issue may result in user being unable to navigate the Navigated Elevate Inserter with the StealthAiR Spine Frame during spine surgical procedures.

Medtronic sent an Urgent - Product Advisory Notice dated May 10, 2017, to all affected customers. Instructions indicated that a Medtronic representative will be in contact to update the system with version 26 and will remove any copies of the Spine Tools Install CD, version 25. Please quarantine any copies of version 25 until they can be removed. If you have further questions regarding this communication, please contact your local Medtronic Navigation Technical Services Representative, your local Medtronic Spine Sales Representative, or call (800 595-9709.

Chests, cabinets and dressers Recalled for Entrapment Hazard

The recalled chests, cabinets and dressers are unstable and can tip over if not anchored to the wall, posing serious tip-over and entrapment hazards that can result in death or injuries to children. The chests do not comply with the performance requirements of the U.S. voluntary industry standard (ASTM F2057-19).

Consumers should immediately stop using any recalled chest, cabinet or dresser that is not properly anchored to the wall and keep it away from children. Contact Noble House Home Furnishings for instructions to receive a full refund. The firm is contacting all known purchasers directly.

Frontier model rotary tillers Recalled for Entrapment Hazard

Some PTO drivelines were assembled without a specified safety sign. The safety sign explains the associated hazards and that an operator or bystander can become entangled if there is contact with the driveline.

Consumers should immediately stop using the recalled rotary tillers and contact an authorized John Deere dealer for a free inspection and repair. John Deere is contacting all known purchasers directly.

FSIS Issues Public Health Alert for Not-Ready-to-Eat, Heat Treated, Not Fully Cooked Chicken Enchilada Products Due to Misbranding and an Undeclared Allergen

Misbranding, Unreported Allergens