Reported Mar 2, 2016 · Terminated
Olympus, Model No. CF-Q160L, flexible scope, large diameter, video colonoscope
Integrated Medical Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integrated Medical Systems Inc · 3200 2nd Ave N · Birmingham, AL · 35222-1212
Is this the product you have?
- Olympus, Model No. CF-Q160L, flexible scope, large diameter, video colonoscope
- Lot codes and dates
- Serial Numbers
20001582203109200041321011132304140220387424054242203295220385325176222101047210229021023022102305210230322036972102317210229722028982203059220347123049222202617241626121021412101633
- Serial Numbers
- Amount recalled
- 26 instruments
This recall covers 22 products
The agency filed one notice per product. You are reading one of them; the other 21 are below.
9 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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