Recall Z-0898-2016 ยท GCQ Endoscope, Flexible
Integrated Medical Systems Inc
Olympus, Model No. CF-Q160L, flexible scope, large diameter, video colonoscope
| Date | Jan 20, 2016 |
| Status | Terminated |
| Reason | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. |
| Root cause | Nonconforming Material/Component |
| Action | The firm notified their consignees of the issue by Fed Ex on 01/20/2016. The firm plans to coordinate with the medical facilities for inspection of the endoscopes. |
| Quantity | 26 instruments |
| Distribution | Distributed US (nationwide) and in Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.