Z-1340-2013 Class II Terminated
FDA device recall Z-1340-2013 was initiated by Linvatec Corp. dba ConMed Linvatec on March 18, 2013 and is designated Class II. 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 … The recall status is terminated (terminated November 6, 2013). Affected quantity: 267 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2013
- Initiation Date
- March 18, 2013
- Termination Date
- November 6, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 267 units
Product Description
Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers images generated by a medical endoscopic camera system during surgical procedures.
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 Pattern
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.
Code Information
VP1600