Recall Z-1488-2013 ยท GDC Table, Operating-Room, Electrical
Berchtold Corp.
Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables
| Date | Jun 6, 2013 (initiated Mar 12, 2013) |
| Status | Terminated |
| Reason | The firm received complaints for unintended movements. |
| Root cause | Device Design |
| Action | Berchtold sent an Urgent Medical Device Recall letter in March 2013, to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were recommended to clean the affected product and use the instructions to reduce the possibility of unintended movements until the firm could replace the affected product. Customers with questions were advised to contact the Berchtold Operon Pendanct Recall Coordinator at 800-243-5135, or 843-569-6100, ext 306. For questions regarding this recall call 843-569-6133. |
| Quantity | 3763 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.