Recall Z-0848-2011 ยท KQM Camera, Surgical And Accessories
Linvatec Corp. dba ConMed Linvatec
Video Cart, Premium 120V product labeling is as follows: REF, VP6501, QTY1, Video Cart, Premium, 120V, Rx ONLY. These Video Carts are intended for storage of Endoscopic equipment that is used in single or multiple surgical specialties MANUFACTURED FOR: Linvatec, LINVATEC CORPORATION, LARGO, FL 33773 USA
| Date | Jan 4, 2011 (initiated Feb 23, 2010) |
| Status | Terminated |
| Reason | ConMed Linvatec, Endoscopy Division, dba. ConMed Linvatec, Largo, Florida is recalling five products: (1.) Video Cart Premium 120 VAC (VP6501), (2.) Video Cart Multi-Specialty 120 VAC (VP6502), (3.) Video Cart Articulating Arm 120V (VP6504), (4.) Video Cart (VP8500), and (5.) Power Cord Assembly Self Retracting (VP6547). These products are being recalled due to there is a possibility that the Vid |
| Root cause | Component design/selection |
| Action | ConMed Linvatec sent URGENT MEDICAL DEVICE CORRECTION NOTIFICATION letters to their customers by FedEx. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to review their plugs for damage and determine if they were affected. Distributors were asked to contact affected customers and schedule delivery of their replacement plugs within 30 days. If the account no longer has the product in their possession, or if they have transferred the product, they were asked to respond as such via a Reply form. Customers were asked to document |
| Quantity | 333 carts |
| Distribution | Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, AND WY and the countries of Canada, Chile, Colombia, Denmark, Korea, Mexico, Singapore, So |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.