Recall Z-1340-2013 ยท KQM Camera, Surgical And Accessories
Linvatec Corp. dba ConMed Linvatec
Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers images generated by a medical endoscopic camera system during surgical procedures.
| Date | May 20, 2013 (initiated Mar 18, 2013) |
| Status | Terminated |
| Reason | The VP1600 HD Still Capture Image System is recalled due to an anomaly between the software code in the VP1600 console and the communications interface for various keyboard key strokes (Caps lock and Num Lock) which may lock up and requires the user to reboot to continue. |
| Root cause | Software design (manufacturing process) |
| Action | The firm, ConMed, sent an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" letter dated 3/8/2013 to its customers after initial phone notifications. The letter identified the product, problem, and actions to be taken by the customers. |
| Quantity | 267 units |
| Distribution | Worldwide Distribution-USA (nationwide) including the Virgin Islands and the states of CA, CT, FL, GA, IN, KY, KS, LA, MD, MI, MN, MO, MS, MT, NE, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, and WI, and the countries of Austria, Belgium, Canada, Denmark, Hong Kong and Zambia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.