FDAFDA · Food and drugs·Recall number Z-0909-2016
Olympus, Model No. CF-Q140L, flexible scope, large diameter, video colonoscope
Published March 2, 2016 · Recall initiated: January 20, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Integrated Medical Systems Inc
- Distributor
- Distributed US (nationwide) and in Australia.
- Lot
- Serial Numbers: 2913081,2600279
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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