FDA Recalls in 2008
610 recalls found
December 2008
Stryker VertePort, 10 G Access Cannula w/Long Stylet System, REF 306-400, Qty 6; For use with the Stryker PCD Precision System and ACM Delivery System, Rx only, sterile, Stryker Instruments, Kalamazoo, MI.
Mis-labeling; The instructions for use include a use for which the device is not intended. (Device not approved to capture a bone biopsy)
Consignees were notified via Medical Device Recall Notification letter dated 2/13/08 to read the enclosed instructions for use, remove all old instructions for use at the consignee location and replace them with the new instructions for use, and to discard the old instructions for use.
EP Healing abutment- Product Code-ITHA52-a pre-manufactured prosthetic component directly connected to an endosseous dental implant.
Package Integrity; sterility compromised-Incomplete seals on the nylon bags in which the product is packed.
Each consignee will be contacted by email or telephone followed by a faxed letter. Each consignee was instructed to check their respective inventory for the recalled part and corresponding lot number. They were directed to return the product to the recalling firm.
Seradyn QMS Vancomycin reagents, Part Number: 0373589. Seradyn, Inc, Indianapolis, IN.
False negative test results due to Interfering substances (heterophile antibodies) in the patient's blood may produce erroneously low results.
Consignees were notified of the problem via Urgent Medical Device Correction letter dated 12/20/07. The letter provided information on the issues concerning the recall. The firm will revise the package insert to address the potential occurrence of false negative bias. If inconsistencies with Vancomycin level exist, confirm with an alternative test method. For further information please contact 1-800-428-4072.
VITALITY DR+ Implantable Cardioverter Defibrillator (ICD), model 1872
Repetitive mechanical stress applied to the titanium case can induce component damage and device malfunction in certain ICD and CRT-D devices implanted subpectorally with the serial number facing the ribs. Devices implanted subcutaneously or in a subpectoral position with the serial number facing away from the ribs are not included in this advisory. This update identifies additional VITALITY ICD
An Urgent Medical Device Information Update to May 2006 Product Advisory, dated January 04, 2008, was sent to implanting physicians and physicians following implanted devices beginning Monday, January 07, 2008. The letter described a malfunction that can occur when the ICD is implanted subpectorally with the serial number facing the ribs. Devices implanted subcutaneously or in a subpectoral position with the serial number facing away from the ribs are not included in this advisory. The physicians were asked to review records to determine if an affected device was implanted subpectorally. An AP radiograph should be done to determine specific device orientation for subpectoral implants. If a subpectoral implant is in a susceptible orientation, consider repositioning or replacement for physically active patients who regularly need device therapy. Follow patients with susceptible devices at 3-month intervals.
Stryker ACL Workstation slider, Model Number: 234-010-503, Stryker, San Jose, CA 95138
Slider Lock Failure - The ACL Workstation slider, a component of the ACL workstation, does not consistently lock into the ACL Workstation Base.
On January 9, 2008, sales representatives were notified via telephone. All consignees were mailed an Urgent: Device Removal notice, dated January 10, 2008. The firm requested that any affected inventory in stock be quarantined and returned to Stryker Endoscopy for destruction. A response form with return postage was included with notification mailed to all consignees.
Siemens Coherence AG Therapist, Part No: 5863506, medical charged-particle radiation therapy system with software version 2.1. Siemens AG, Concord, CA.
Image Orientation Incorrect (Image Shifts) - 1) if the reference image has been calibrated for centering and the reference image is used for patient positioning, the image will shift when the positioning tools are used. 2) This problem occurs only when non-square reference images are used, such as when images are cropped. At this point, the images will refresh, and the center of the reference im
On 10/03/2007, the firm sent Consignees a Customer Safety Advisory Notice informing them of the two potential issues with the display of reference images used for position correction. Consignees will be informed when a solution to this issue has been validated.
Radiation Protective Eyewear (only involving multifocals. FTC 28 Progress X-Ray Protective Eyewear Protective Eyewear is not sent with any package inserts or labeling. It is sent is plain envelope, bag of box.
Radiation Protective Eyewear does not meet the radiation protection levels stated on the labeling.
Customers were all notified by phone, followed by an Urgent Recall letter dated June 3, 2008. The letter asked that customers examine their stock immediately to determine if they had any of these radiation protective bifocals on hand, discontinue use or distribution of the lot, and set the products aside for further instructions. Also, if customers distributed these items, they needed to contact their accounts and advise them of the recall and have them return their outstanding recall stock to them. The firm will send replacement products in the weeks to follow.
Thin-Flex Venous Return Cannulae, 33/43 FR. x 39 cm, REF TF3343O, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614 Intended for cannula drainage of the superior and inferior vena cava during extracorporeal circulation for a duration of less than and equal to 6 hours.
Reinforcement spring may detach from the cannula body resulting in reduced venous blood return flow.
All domestic consignees were notified by a Product Recall letter on 07/15/2008 via FedEx. They were instructed to check their inventory for any affected product and return all unused product from their stock to Edwards. Customers are to contact Customer Service Organization to obtain a Returned Goods Authorization number and replacement product. Once inventory has been verified, the attached form needs to be completed and faxed to Edwards so that customer awareness can be confirmed. International accounts were notified on 07/14/2008.
SERVO-i Ventilator System Maquet Critical Care, Solna, Sweden. The product is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency.
Maquet became aware of potentially defective crimpings at the point connector attached to the cable in SERVO-i and SERVO-s ventilators.
Urgent - Device Correction notices were sent out to all customers on July 7, 2008. The letter informed the customers of the affected product, and associated hazards. The letter instructed customers to take an inventory of the product and it provided actions to be taken until affected products are replaced. Contact Maquet at 1-888-627-8383#1, for assistance.
Cannabinoids Intercept Micro Plate EIA 100 plate kit
Readings, high: intermittent high absorbance readings. For further information, please contact the firm at 610-882-1820.
On 9/8/08, the recalling firm telephoned the customer to inform them of the problem. As a follow up to the telephone call, the recalling firm issued a recall letter dated 9/11/08 to the customer.
Psi Bands acupressure/acustimulation wrist bands in the following colors: Racer Black (UPC 859570001036), Daisy Chain (UPC 859570001029), Color Play (UPC 859570001043) and Cherry Blossom (UPC 859570001012).
Product was marketed before its 510(k) application cleared.
Recall imitated 04/26/07. Retailers were informed via phone and email and mail. The product was marketed prior to the firm receiving clearance to market from the FDA. Contact Carla Falcone at 831-373-7712 if you have questions.
Iris Sample Processing SafeCrit 75mm Tubes. Iris Sample Processing, 60 Glacier Drive, Westwood, MA 02090. Heparin-treated capillary tube used for spun hematocrit packed cell volume (PCV) determination.
presence of OSCS contaminant
The recalling firm issued recall letters dated 8/1/08 via certified mail to the label owners informing them of the problem and the need to notified their customers.
OSI, Allegro 6800 Imaging Table (Operating), single pedestal AC or battery operated table, Orthopedic Systems, Inc., Union City, CA
Failure to anchor; due to a failure in the locking mechanism, the product may not anchor properly.
The firm issued a Product Correction Notification letter by mail on 02/28/2007 and follow up with phone calls. The letter notified users that a required no-cost upgrade of the removal and replacement of a microprocessor that controls the logic for the floor locking mechanism will be conducted by the recalling firm.
Zimmer M/G Unicompartmental Knee System headed screw, 48 mm length, sterile, Catalog No. 00-5791-041-00. Used during surgery for the cutting guide. This screw is not permanently implanted.
An impurity in the metal may affect the strength of the screw, resulting in breakage and/or surgical delays.
Zimmer instructed consignees by a letter, dated June 30, 2008, sent via mail or email, to return the product.
Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999LV1, Exu-Dry Large Burn Vest, Smith & Nephew, Inc.,Largo, Florida
Sterility (package integrity) compromised: Distribution of product that did not meet specifications; open seals.
Consignees were notified of recall by certified mail, Urgent Device Recall letter dated 11/21/2007, which was sent to each consignee. The recalled product will be returned to the firm by pre-paid FedEX return labels. A second letter is to be issued to each distributor for recall to the retail level, as the firm's original recall strategy of distributor level recall, was deemed inappropriate by CDRH
Laser Distance and Level Transmitters, Model No. LT4C, ASI, 8570 Katy Freeway, Suite 117, Houston, TX 77024
Failure to comply with Federal Laser Product Performance Standards (21 CFR 1040.10, 1040.11, 1002.10-improper classification, incomplete labeling, incomplete user information and failure to submit required product reports)
The firm notified its consignee of problem and the field correction by letter dated 11/03/2006.
EndoVive Safety PEG Kits 24 F Universal Product Number (UPN): MOO56648 1 The product provides nutrition directly into the stomach of adult and pediatric patients who are unable to consume by conventional methods.
Mislabeled: Inner box labeled 20 Fr PEG, outer and tray label correctly labeled 24 Fr PEG
Boston Scientific notified customers by priority Express Mail on June 17, 2008. The notification instructs accounts to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. Contact Boston Scientific Corporation at 1-800-272-3737 for assistance.
Oscor Adelante Luer-Lock Peel Away Introducer Set, for introduction of diagnostic or therapeutic devices into the body.
Difficulty breaking the sheath hub and subsequently to peel the sheath off for Introducer Set, Adelante size 7F.
Oscor notified the Direct Account by letter on 07/03/2008. Direct account was asked to return all unused Introducers back to Oscor. All returned products should be labeled with the Return Goods Product number.
Alpha-Omega Services, Inc. Product No: NFV0001-004 Description: NEEDLE, FLEXIGUIDE: SERIES-15, 25CM, WITH FEMALE LUER ADAPTOR, SHARP AND STYLET WITH MALE LUER ADAPTOR (HDR); 10/PKG Quantity: 10/PKG L-NFV0001-004. The FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method.
There is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles tip to leak, thereby breaking the sterile boundary and possibly contaminating other devices with body fluids.
Notification of customers initially began November 15, 2007 based on a cursory visual inspection of the defective needle tips. The initial letter advised that there is a possibility that the Flexiguide Needle tip is defective in that there is the potential for the needle's stylet or an HDR source wire/cable to puncture through the defective needle tip during implant or treatment and penetrate the surrounding tissue thereby injuring the patient and/or breaking the sterile boundary. Further distribution and/or use of these products should not take place. The recall notification was updated on November 27,2007 once results from actual testing were available. The letter advises that there is a potential for the needle's tip to leak, thereby breaking the sterile boundary and possibly contaminating other devices with body fluids. Further distribution and/or use of these products should not take place. Customers are to return the products for credit. A response form is provided. Contact Alpha-Omega Services, Inc. at 1-800-346-7894 for assistance.
Nova - EZ CHEM Creatinine Meter: SRS Versions 5.1 and 5.2 P/N 9600, Nova Biomedical, Waltham, MA 02454
Incorrect Results - Creatinine results were lower than the laboratory reference method.
Nova Biomedical issued an Urgent: Medical Device Recall notification letter to consignees dated November 19, 2007. The letter addressed the issues with the product(s) and requested that if users had any remaining stock that it must be returned. The firm also provided a Customer Response form to be returned. Questions concerning this recall will be addressed by Gina Vogelsberg at 1-800-544-4624 or by email at gvogelsberg@ezem.com.
AS3000 Anesthesia Delivery System. Datascope Patient Monitoring; A Mindray Global Company. The AS3000 is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.
Two issues have been identified with the AS3000 unit. 1. The threadlocker of the caster (wheels) may not have been utilized, which may allow the caster to loosen and possibly separate from the unit. 2. The use of select brands of pre-pack absorber in the absorber canister of the AS3000 has been associated, in some cases, with gas leakage around the pre-pack, rather than through the absorber mate
Notification (Urgent Product Field Correction) letters were sent to the one consignee on October 7, 2008 by Federal Express overnight delivery.
Proven Cemented Semi-Constrained Total Knee. Part number SC1591. The size is 38 and the thickness is 10 mm. The Proven Knee System is a single use device intended for cemented reconstruction of the femoral and/or tibial portion of severely disabled and/or painful knee joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis with or without varus, valgus or flexion deformities, and revision surgery provided that there is radiographic evidence of sufficient sound bone to se
Five (5) Three Peg Patella SC1591-29 were packaged in containers labeled for SC1591-38 sharing the same lot number.
On 9/4/08, the recalling firm telephoned their customers to inform them of the problem and asked them to immediately recover all SC1591-38 with lot number 19906-052008. Once the product is in their possession, customers should contact Stelkast Customer Service for a Return Authorization (RA) Number prior to shipment to Stelkast.
PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888123411, Size 14.5Fr/Ch (4.85mm) x 23cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for th
Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used.
Starting on 9/19/08, Covidien Sales Representatives visited each of the hospitals that received the catheters, informed the staff that the Venetrac insertion stylets were too short, and placed pink corrective sticker labels on any unused product. Should you require additional information, please contact jim.welsh@covidien.com or 508-216-8532.
BI-700-00027 0-arm 1000 Imaging System Mobile X-ray System Generating 2D and 3D images of human anatomy for surgical applications.
Failure to of affected units to comply with EER/AKR limits due to misinterpretation of the measurement requirements specified in 21 CFR 1020.32 (d) (3) (iii)
Medtronic Navigation notified service engineers to retest units for compliance.
GE Healthcare Centricity Perinatal (formerly Quantitative Sentinel) System - Alert and Reminder software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit; GE Healthcare Integrated IT Solutions, Barrington, IL 60010 Intended for use as a clinical data management system.
Software anomalies in the Alert and Reminder feature could result in a delay of treatment. When attempting to select the last visible alert or reminder choice, the next choice on the list below the desired choice is selected, and an inconsistent color may be displayed for the same clinical element across a set of work stations.
The software was updated to version 6.80.1 on 4/22/08, however, the consignee was notified of the software defects relating to the last visible Alerts and Reminders choice and the inconsistent display for the same clinical element across a set of work stations, via Product Safety Notification letter dated 8/29/08, sent via first class mail on 9/24/08. If there were any questions, the customer was to contact Tech Support at 1-800-433-2009.
Myelotec Steerable Video Guided Catheter, 2.7mm, label insert for LB0013-1, LB0013-2, and LB0013-3. (product code: 2000) Myelotech, Roswell, GA 30076.
Incorrect Labeling information: Product may contain inappropriate information in its label insert that refers to the product's use with energy delivering instrumentation.
Consignees were first notified by phone on 12/19/2007. A follow up Urgent Label Insert Recall Notification letter was sent via certified mail on/about 12/28/2007. Consignees were instructed to remove the subject label inserts from the affected product in inventory, replace with the enclosed revised label inserts and to complete the attached Recall and Accountability Form. The incorrect label inserts were to be returned, via package provided to Myelotec.
Heartport Direct Flow Arterial Cannula, product code DFK24. The device is sold separately and also in the following Kit Model Numbers: EDNN241, EDnn242, EDNN243, and EDNN244.
During cardiopulmonary bypass (CPB) the distal tip of the arterial cannula can become disconnected from the body of the cannula.
The recall was initiated on 4/27/2006. The hospitals were notified via letters to the Director of Material Management, Director of the OR as well as the Director of the Cardiovascular Suite in the US. The letters were sent via certified mail delivery. For international, notification was made to the J&J affiliates (Gargrave and Italy) by the European Authorized Representative. Each country will follow local procedures for notitying customers.
"LOCATOR Abutment for 5.7 Screw-Vent & Compatibles." Zest Anchors, Inc. Product is sold for use with any Zimmer Dental 5.7 mm diameter Tapered Screw-Vent Implant. The product is used with supra-gingival, universal hinge, resilient overdenture attachment for endosseous implants.
The recall was initiated after the firm discovered through a customer complaint that the Locator Abutments for 5.7 Screw-vent & Compatibles do not fit properly in all sizes of the Zimmer Dental 5.7mm diameter Tapered Screw-Vent Implants (TSV6B8, TSV6B10, TSV6B11, TSV6B13, TSV6B16, TSV6H8, TSV6H10, TSV6H11, TSV6H13 and TSV6H16). The Locator Abutment bottoms out in the pilot hole of these implants c
The recall notification letter (Recall Notice) was sent to consignees on April 23,2008. The letter includes the following information on how to handle the recall. It is very important that you determine the use of the Locator Abutment(s) as follows, mark the appropriate box, ,and return this letter to Zest Anchors, Inc. in the stamped, self-addressed envelope: 1. The Locator Abutment(s) listed above WERE NOT used on any Zimmer Dental 5.7mm diameter Tapered Screw-Vent Implants. THE FIT IS CORRECT AND NO ACTION IS NECESSARY. 2. The Locator Abutment(s) listed above WERE used on a Zimmer Dental 5.7mm diameter Tapered Screw-Vent Implant. PLEASE CONTACT OUR DENTAL OFFICE TO ARRANGE THE R PLACEMENT OF THE ABUTMENT WITH A NEWLY DESIGNED LOCATOR ABUTMENT. and 3. We have current STOCK of the Locator Abutment(s) listed above with planned use for a Zimmer Dental 5.7mm diameter Tapered Screw-Vent Implant. PLEASE CONTACT OUR DENTAL OFFICE TO ARRANGE THE REPLACEMENT OF THE ABUTMENT WITH A NEWLY DESIGNED LOCATOR ABUTMENT. For questions or additional information, contact Zest Anchors, Inc. at 800-262-2310 or 760-743-7744.
TomoTherapy Hi-Art System with software versions 3.0 and 3.1 - Radiation Therapy System. The device is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy.
Registration adjustment field numbers may appear on printed pages of the Register Tab as nonsense characters or values different than the numbers shown on the Operator Station (OS) display. Setup will move the couch to the correct offset position. If the couch is manually adjusted to the incorrect value, the patient may not be the correct position during treatment.
Consignees were sent a letter "TomoTherapy Incorporated Urgent Medical Device Correction Field Safety Notice" dated February 22,2008. The letter described the Issue, Product Affected, Cause, Recommended Customer Action and Resolution. If you have not received this letter or have questions, contact the firm as outlined below: North America: 1 866 368 4807 Belgium: 0800 38783 France: 0805 631 565 Germany: 0800 000 7541 Italy: 800 986 399 Netherlands: 0800 0201364 Spain: 800 300049 Switzerland: 0800 001927 United Kingdom: 0808 238 6035 China/CNC (Northern): 10 800 712 1701 China (Southern): 10 800 120 1701 Hong Kong: 800 967912 Japan: 0044 22 132374 Singapore: 800 1204 683 South Korea: 0079 81 4800 7204 All other locations: +1 608 824 2900 or +32 2 400 44 44
Medtronic Trillium AFFINITY NT, 511T, Hollow Fiber Oxygenator with Trillium Biopassive Surface, with Plasma Resistant Fiber. MODEL Numbers: 95215, 95216, 95217, 95249, 95250, 95252, 0H46R28, 0M81R41, 0R35R13, 0Y95R22, 1702R51, 1A11R16, 1A19R26, 1B22R5, 1F66R12, 1G47R4, 1K86R3, 1K93R5, 1L71R20, 1M05R12, 1P07R6, 1X24R, 2892R18, 2D64R12, 2E55R9, 2N90R8, 2V85R4, 3B89R12, 3C98R7, 3P11R4, 3R39R2, 3R42R14, 4B46R16, 4E58R16, 4F13R2, 4J01R7, 4Q39R1, 4R68R5, 4R68R6, 4W65R, 4X44R7, 5633R30, 5C89R2, 5D83
Medtronic is advising that certain Trillium-coated Medtronic cardiopulmonary bypass (CBP) products (e.g., oxygenators, reservoirs, pumps and tubing packs) were manufactured with heparin batches contaminated with oversulfated chondroitin sulfate (OSCS). Based upon currently available information, Medtronic has determined that Medtronic Trillium-coated products can continue to be used in cardiopulm
Medtronic Cardiovascular Customers were sent the May 05, 2008 Urgent Medical Device Corrective Action letter to advise them that certain Trillium-coated cardiopulmonary bypass products were manufactured with heparin which may be contaminated with oversulfated chondroitin sulfate. The letter discussed the risk evaluation and gave recommendations to healthcare professionals for patient care. Affected devices can continue to be used in cardiopulmonary bypass procedures.
Outback LTD Re-Entry Catheter, Sterile, Single Use. The Cordis LuMend OUTBACK LTD Re-Entry Catheter is indicated for placement and positioning of guidewires within the peripheral vasculature. The cannula is a nitinol needle that is used to re-enter the true lumen of the vessel.
The Cordis LuMend Outback LTD Re-Entry Catheter - separation rate of the cannula to the deployment slide of the handle assembly is higher than anticipated. The cannula is unable to be retracted into the device after deployment due to a separation of the inner key from the cannula.
U.S. Customers - A Notification of Recall Letter with an Acknowledgement Form was sent overnight to 5 individuals in each account on 08/18/2008. For non-U.S. customers, email notification with return acknowledgement is used to notify the affiliate distributors, who then notify and reconcile the customers in those countries (08/18/2008). Contact Cordis special Customer Service at (800) 551-7683 for assistance.
November 2008
Electronic Otto Bock Compact leg prosthesis System, 3C95/3C85, to be used exclusively for the exoprosthetic fitting of amputations of the lower limb. Microprocessor-controlled prosthetic knee joint used by lower extremity amputees.
A correction of the Otto Bock Compact prosthetic knee joint, material numbers 3C93 and 3C85, is being conducted. A limited number of Compacts have a defective solder connection between the contact wires and battery terminals. If exposed to strong vibrations these Compact knee joints have an increased probability of malfunction and a resultant risk to the Compact wearer.
An Urgent Correction Notice, dated August 11, 2006, was sent to customers who purchased the Compact Prosthetic knee joint. The letter identifies affected units, asks for all in stock devices to be returned to Otto Bock, and for patients fitted with an affected device, a loaner knee will be provided as a temporary replacement while their device is serviced.
Product is packaged and labeled as: ''Cordis PRECISE Nitinol Stent Transhepatic Billiary System'', Catalog Nos. N820SB, N830SB, N840SB, N920SB, N930SB, N940SB, N1020SB, N1030SB, N1040SB only. This recall also affects Cordis PRECISE Nitinol Stent System, not distributed in the United States, Catalog numbers, N920SC, N930SC, N940SC, N1020SC, N1030SC and N1040SC only.
Field complaints of marker band spacing being out of spec.
The firm sent, via First Class Mail, a Recall notification Letter with Response Card on 11/7/02. The letter asks for response from the user accounts and for return of product. The letter includes a UPS label for return of product. Non-responders will be recontacted as part of the firm''s effectiveness checks.
Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters.
Sterility (package integrity) compromised-Cordis Neurovascular, Inc. discovered, during internal testing, that some catheters within the affected lots of CNV preshaped PROWLER and pre-shaped PROWLER SELECT Infusion Catheters may have a pinhole or tear in the Mylar pouch, which may result in a compromise of the sterility inside the pouch.
All consignees were notified by letter on 8/14/06. All Cordis Neurovascular sales representatives will also participate, to ensure expedited communication.
AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems
Software anomaly-A software defect can cause the slice line indicator to become mis-positioned during Multi-Planar Reconstructions (MPR) with the potential for patient mis-diagnosis.
The firm''s Field Service personnel will apprise the customers of this situation during scheduled visits at each customer location. During this visit, the corrected software will be installed by the Hitachi Field Service Technician. The installation of the software upgrades by the service technicians began on 4/28/2006. The firm anticipates that the correction of all units in their inventory as well as those units installed out-in-the-field will becompleted by 6/15/2006.
Medtronic iCon Patient Programmer, model 3037. The Patient programmer is a hand held, battery operated, microcontroller based device for use by patients to control and monitor external and implantable devices. The minimum amount of control involves the ability to turn therapy ON or OFF; maximal control allows the patient to select from different therapies and adjust the parameters with in the set therapy limits.
Medtronic is retrieving four (4) patient programmers that were not properly loaded with application software. The application software is needed for a patient programmer to synchronize and bond with a neurostimulation device. Without this functionality a patient programmer is not useable and can not communicate with a neurostimulation device.
A letter was sent to each account telling them of the issue and to let them know that Medtronic is retrieving the affected devices. Medtronic Reps were to visit affected accounts to notify them of the recall, locate the affected device and return it. Rep is to complete the reply card and fax to Medtronic Neuromodulation. If you have questions, contact your Medtronic representative or Medtronic Neuromodulation Technical Services at 1-800-707-0933.
Vistabritetip IG Introducer, Introducer Guide. Labeled as sterile, sterilized with ethylene oxide gas. For single use only. Catalog number 4038553S
The product is labeled as Straight Catheter but the package contains Contralateral Guide shaped Catheters.
A recall letter dated 04/30/2004 was sent to the consignees, instructing them to discontinue using the product and informed them that a Cordis representive would remove any unit in their possesion.
Product is packaged in a box and is labeled: Syphilis TREP-CHEK No. 720-100-10, 960 test, For in Vitro Diagnostic Use Lot 71303 Exp. Jun 04 Diamedix, A subsidiary of IVAX Diagnostics, Inc. MIAMI, FL 33127
The test kit may have the potential to give erroneous results in that it may give higher frequency of equivocal/low positive results.
A recall notification letter was mailed to each consignee/user account on 12/9/2003 telling them that the recalled lot may give a higher frequency of equivocal/weak positive results. It requests them to discontinue use and to return the product to them. Also they are asked to sign and date the bottom of the recall letter and fax it back to the recalling firm.
superDimension Bronchus System (AAS00016-01), an image-guided localization system used to guide endoscopic tools to predetermined targets within the pulmonary tract.
The action is being taken in response to certain incidents that have been reported to the company, one of which concerned an adverse event in which a patient incurred a pneumothorax during a procedure in which a superDimension Bronchus System was used. The biopsy results for the patient were taken from a different area than the confirmed navigation site that was indicated by the system.
An Urgent Medical Device Field Action letter, dated 11/30/2006, was sent to medical facilities who have the superDimension Bronchus System installed. The letter infoms the facility to immediately stop using the Bronchus System, and move all inventory of the disposable system components to a controlled quarantine area. A superDimension representative will contact the consignees to schedule a time to retrieve the quarantined inventory, at which time a verification form will be completed.
Product is a Powerflex P3 Dialation Catheter. Product is labeled in part: ''***POWERFLEX P3***Cordis***a Johnson and Johnson company***ENDOVASCULAR***STERILE EO***Cordis Europa N.V., 9301 LJ Roden, The Netherlands***''
During competitive product testing, wire movement difficulties were observed in Powerflex P3 units. Due to the possibility of user inconvenience, Cordis is recalling the six affected lots of Powerflex P3. There is no patient impact.
Recalled by letter and Cordis Sales Representatives interfacing directly with US consignees.
SoftPath GUI Release Software Versions 3.17 and 4.1. Used in pathology laboratory for receiving accessing specimen reports, billing and management reports for surgical, GYN, NON-GYN and Autopsy cases.
Loss of text misrepresented individual tissue diagnosis on the final diagnosis print out from the HIS system software. The specimen heading "J" was removed and the diagnosis appeared under the specimen heading "I" as a result the specimen with the heading "I" had two diagnosis.
Software corrections were sent as of 10/30/2003 for clients to upgrade to, the correction software patch is in versions 3.17.5.16, 3.17.6.10, 3.17.7.3 and 4.1.1.0. The firm did not inform the non-affected consignees of the failure because the firm concluded that the associated risk was low.
Product is SoftPath ASCII Software Releases 1.2, 2.1, 2.2, and 2.3.
In the creation of revised report and supplemental reports diagnosis, text was inserted from another case.
Consignees were notified of recall and provided with a software correction patch ICC number 3618.
Syngo Imaging with versions VB20B, VB20D, VB20F, VB20G, VB25B, VB30A, VB30A_SP1, and VB30A_SP2.
Image may not be visible after merge.
The recalling firm issued Customer Safety Advisory Notice dated 8/22/08 to inform the consignees of the potential issue and provide instruction to avoid its occurrence. To avoid potential risk of this issue, users are asked to check whether the extended HL7 messages as stated in the letter are mandatory for their RIS-PACS workflow, and disable these messages if they are not. Siemens is preparing a modification under the UI IM086/08/S for the affected versions of syngo Imaging that will resolve the potential malfunction. The field modification will be immediately distributed and installed by the firm's Service as soon as it is available.
VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous Catheter.
Two complaints have been received and confirmed, regarding a lot, indicating that the distal end had an 'RDC' shape rather than the 'RDC(1)' shape. The RDC shape has a larger curve. The product was manufactured with the incorrect forming wire during the guiding catheter manufacturing process.
Packets containing the Customer Letter and Acknowledgement Form for each domestic consignee were sent by overnight delivery to the appropriate Cordis Endovascular sales representatives. The letter is being hand-delivered to each initial domestic consignee by the Cordis Endovascular sales representative. Any remaining units at the account will be removed from the shelf and returned to Cordis. The account will be asked to sign the Acknowledgement Form.
Cypher Sirolimus-eluting Coronary Stent on Raptor Over-the-Wire Delivery System (CWSxxxxx), and Cypher RX Sirolimus-eluting Coronary Stent on RaptorRail Rapid Exchange Delivery System CXSxxxxx
Inventory control stickers had incorrect expiration date. The stickers stated the expiration date was November 2004 instead of October 2004.
The firm issued a removal of Cypher Product with Incorrect Inventory UBD Sticker letter to its customers in November 2004. The letter instructed them to return the product for credit. It also had an acknowledgement form and requested the consignees complete the acknowledgement form and fax back to Cordis. The firm intends to destroy the returned product.
Product is Cordis Brite Tip Catheter Sheath Introducer (4, 7, 8, 9, 10 and 11French sizes only).
Reports of broken or separated tips of the catheter sheath introducers.
Cordis provided their national sales force with a recall package for each customer for that representative's area for visits on 5/5/2003. The sales reps were to visit each hospital/medical facitliy to present them with the Recall Letter (dated 5/5/2003) and also a Question and Answer Sheet. The sales rep will search and quarantine for return all involved products in the customers inventory. The sales representative and customer will fill out and sign response forms and return them and the recalled product to 'Cordis Returned Goods' in Miami Lakes, FL. Due to delays in completing the visits the firm sent the same Recall Letter to all accounts that had not been visited yet on 5/30/03. In addition the Sales Reps will still visit the remaining accounts and recover recalled product.
CORDIS SV-5 Steerable Guidewire, 180 cm., 5 Steerable Guidewires, Cordis a Johnson Johnson Company, ENDOVASCULAR, Manufactured for: Cordis Corporation, Miami, FL 33102-5700. USA, Catalog # 503558.
Tip separation-Cordis SV-5 and SV-8 Steerable Guidewires may have a potential for guidewire fracture resulting in tip separation.
A recall of all lots manufactured by the OEM was initiated by letter dated July 21, 2006. All lots of the SV-5 guidewire and related design SV-8 guidewire were placed on Stop Shipment 6/30/06.
Syn go Imaging XS is a picture archiving and communication system intended to display, process, read, report, communicate, distribute, store and archive digital radiological images, including digital mammography images.
The firm discovered a problem where the selected patient images on the device may display an additional image from another patient or study.
The recalling firm issued a Customer Safety Advisory via certified mail to affected customers per Update Instructions IM011/08/S. The letter informs customers of the potential issue and provides instructions to detect its occurrence. A software update to correct the issue is already available. A service representative will visit affected sites to install the software update. If you have questions concerning the advisory letter or you did not receive a letter contact Alexander Vogel at +49 (9131) 84-3840 or alexander.vogel@siemens,com and make reference to complaint 08-1KM-0073 date 2008-03-06.
Infinity Docking Station (IDS) Delta and Kappa Series patient Monitors. Model numbers 4715319, 5206110, 5732388, and 7489375.
Top cover of assembly may separate. The situation can result in the monitor falling, which could result in an injury to the clinician or patient.
The recaling firm issued a recall letter to the US customers 11/17/2006 via certified mail. An authorized service representative will inspect each potentially affected unit. If a unit is found to have an affected docking station, the unit will be repaired or replaced free or charge. Notification to international customers will occur through the international subsidiaries.
Cordis INFINITI 6 French Diagnostic Catheter. Catalog 534-6xxT. That is: 534614T, 534615T, 534617T, 534618T, 534619T, 534620T, 534621T, 534622T, 534623T, 534624T, 534625T, 534627T, 534628T, 534629T, 534635T, 534637T, 534641T, 534642T, 534643T, 534644T, 534645T, 534646T, 534647T, 534648T, 534649T, 534660T, 534670T, 534672T, 534674T.
The tip of the catheter may separate from the body during operation.
The firm sent a letter in June 2006 to its consignees advising them that all impacted lots of Infiniti 6 French catheters (product codes attached) manufactured on Line #1 from July 2005 through February 2006 are being recalled, starting June 26, 2006. The U.S. initial consignee is being contacted directly by Cordis sales reps and other Cordis representatives. The initial consignee is being requested to sign an Acknowledgement Form. The Cordis representative is collecting any units at the consignee, and sending the units back to Cordis for reconciliation and destruction.