Recall Z-2148-2012 ยท FWH Camera, Cine, Surgical, Without Audio
Berchtold Corp.
Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual recording of surgical procedures.
| Date | Aug 6, 2012 (initiated Jul 10, 2012) |
| Status | Terminated |
| Reason | Defective camera: There is a possibility that the connection of the wires to the connector may become loose, causing image distortion or loss. |
| Root cause | Nonconforming Material/Component |
| Action | BERCHTOLD Corporation sent a letter dated July 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. BERCHTOLD will replace the customer's cameras at no cost to the customer. Customers with questions should call 843-569-6100, ext 322. For questions regarding this recall call 843-569-6100. |
| Quantity | 17 cameras |
| Distribution | Nationwide Distribution including FL, MI, MS, and NH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.