Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers images generated by a medical endoscopic camera system during surgical procedures.
This recall has been terminated (originally issued May 20, 2013).
- Recall Initiated
- March 18, 2013
- Posted
- May 20, 2013
- Terminated
- November 6, 2013
- Recall Number
- Z-1340-2013
- Quantity
- 267 units
- Firm Location
- Largo, FL
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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.
Lot / Code Info
VP1600
Root Cause
Software design (manufacturing process)
Action Taken
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.