Recall Z-0417-05 ยท GCJ Laparoscope, General & Plastic Surgery
Stryker Endoscopy
Video cart shelf system for organizing with three styles: standard, multispecialty, and auxiliary. Isolation Transformer provides power to devices, also sold separately.
| Date | Jan 27, 2005 (initiated Nov 30, 2004) |
| Status | Terminated |
| Reason | A problem with the design of the transformers may cause the transformers' circuit breakers to trip, which could result in loss of power to connected medical devices. |
| Root cause | Device Design |
| Action | The firm has initiated consignee notification by sending a notification letter and acknowledgement of receipt cards to its consignees. Service cards will be issued to firm sales representatives. |
| Quantity | 256 carts with transformers, 20 transformers |
| Distribution | The products were distributed to 114 consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935234 | STRYKER ENDOSCOPIC VIDEO ACCESSORIES Stryker Endoscopy, Mar 18, 1994 |