Olympus CF-Q160L Video Colonoscopes Recalled for Detached Internal Coil Pipe Assembly
Integrated Medical Systems Inc is recalling 26 Olympus CF-Q160L video colonoscopes because excessive pressure can cause the internal coil pipe assembly to detach, preventing angulation from operating as intended.
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 (detached coil pipe) that prevents the device from operating as intended, posing a risk of harm during a medical procedure without reported injuries.
Plain-English summary
Integrated Medical Systems Inc is recalling 26 Olympus, Model No. CF-Q160L, flexible scope, large diameter, 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. When this occurs, the angulation of the endoscope may not operate as intended.
The affected instruments were distributed nationwide in the United States and in Australia. The specific serial numbers for the 26 recalled units are: 2000158, 2203109, 2000413, 2101113, 2304140, 2203874, 2405424, 2203295, 2203853, 2517622, 2101047, 2102290, 2102302, 2102305, 2102303, 2203697, 2102317, 2102297, 2202898, 2203059, 2203471, 2304922, 2202617, 2416261, 2102141, and 2101633.
Healthcare facilities and users should check their inventory for these specific serial numbers. If an affected instrument is found, it should be removed from service and returned to Integrated Medical Systems Inc for repair or replacement.
The recalled product
- Product
- Olympus, Model No. CF-Q160L, flexible scope, large diameter, video colonoscope
- Manufacturer
- Integrated Medical Systems Inc
- Category
- Medical Device — Endoscope
- Affected units
- 26
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: 2000158
- 2203109
- 2000413
- 2101113
- 2304140
- 2203874
- 2405424
- 2203295
- 2203853
- 2517622
- 2101047
- 2102290
- 2102302
- 2102305
- 2102303
- 2203697
- 2102317
- 2102297
- 2202898
- 2203059
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 Video Colonoscopes Recalled Due to Internal Coil Detachment Risk
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- HighOlympus Video Gastroscope Recall Due to Detached Internal Coil Assembly
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- HighOlympus Video Colonoscope Recall Due to Internal Coil Detachment Risk
FDA (Devices) · 2016-03-02
- HighOlympus Video Gastroscope Recall Due to Internal Coil Detachment Risk
FDA (Devices) · 2016-03-02
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