Olympus, Model No. CF-Q140L, flexible scope, large diameter, video colonoscope
This recall has been terminated (originally issued January 20, 2016).
- Company
- Integrated Medical Systems Inc
- Recall Initiated
- January 20, 2016
- Terminated
- October 13, 2016
- Recall Number
- Z-0909-2016
- Quantity
- 2 instruments
- Firm Location
- Birmingham, AL
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Distributed US (nationwide) and in Australia.
Lot / Code Info
Serial Numbers: 2913081,2600279
Root Cause
Nonconforming Material/Component
Action Taken
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.