Recall Z-0905-2016— Integrated Medical Systems Inc
Class II · Terminated
Class II FDA medical device recall by Integrated Medical Systems Inc, initiated 2016-01-20, terminated 2016-10-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Olympus, Model No. TJF-160F, flexible scope, large diameter, video duodenoscope. 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..
- Recalling firm
- Integrated Medical Systems Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-01-20
- Terminated
- 2016-10-13
- Firm location
- Birmingham, AL, United States
Product description
Olympus, Model No. TJF-160F, flexible scope, large diameter, video duodenoscope
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.