Olympus Video Colonoscope Recall Due to Internal Coil Detachment Risk
Integrated Medical Systems Inc. is recalling 43 Olympus CF-Q160AL video colonoscopes because excessive pressure can cause the internal coil pipe to detach, preventing proper angulation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical failure that could compromise the device's intended function during a medical procedure, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Integrated Medical Systems Inc. is recalling 43 Olympus Model No. CF-Q160AL flexible video colonoscopes. The recall is due to a defect where excessive pressure applied to the distal end of the endoscope can cause the internal coil pipe assembly to become detached. If this occurs, the angulation mechanism may not operate as intended.
The affected instruments were distributed nationwide in the United States and in Australia. The recall covers specific serial numbers listed in the agency's official documentation.
Healthcare facilities and users should stop using the affected instruments and contact Integrated Medical Systems Inc. for instructions on repair or replacement. Consumers should not attempt to use these devices if they are in their possession.
The recalled product
- Product
- Olympus, Model No. CF-Q160AL, flexible scope, large diameter, video colonoscope
- Manufacturer
- Integrated Medical Systems Inc
- Category
- Medical Device — Endoscope
- Affected units
- 43
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial Numbers: 2427253
- 2528563
- 2315445
- 2314847
- 2212887
- 2315826
- 2000027
- 2314864
- 2315955
- 2213834
- 2212872
- 2315727
- 2315729
- 2213866
- 2416648
- 2427952
- 2416195
- 2314929
- 2111326
- 2416125
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Integrated Medical Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 22 products in this recall →Related recalls
Same manufacturer · Integrated Medical Systems Inc
See all →- HighOlympus Video Gastroscope Recall Due to Internal Coil Detachment Risk
FDA (Devices) · 2016-03-02
- HighOlympus CF-Q160L Video Colonoscopes Recalled for Detached Internal Coil Pipe Assembly
FDA (Devices) · 2016-03-02
- HighOlympus Video Colonoscopes Recalled Due to Internal Coil Detachment Risk
FDA (Devices) · 2016-03-02
- HighOlympus Video Gastroscope Recall Due to Detached Internal Coil Assembly
FDA (Devices) · 2016-03-02
- HighOlympus Video Colonoscope Recall Due to Internal Coil Detachment Risk
FDA (Devices) · 2016-03-02
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