Olympus Video Colonoscope Recall Due to Internal Coil Detachment Risk
Integrated Medical Systems is recalling five Olympus video colonoscopes because the internal coil pipe assembly may detach if excessive pressure is applied to the distal end.
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 prevent the device from operating as intended, posing a risk of harm without reported injuries.
Plain-English summary
Integrated Medical Systems Inc is recalling five Olympus Model No. PCF-160AL flexible video colonoscopes. The recall involves specific serial numbers: 2123053, 2337714, 2338700, 2337727, and 2112612. These instruments were distributed nationwide in the United States and in Australia.
The recall is being conducted because if excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end can become detached. When this occurs, the angulation of the scope may not operate as intended. This defect could compromise the functionality of the device during use.
Healthcare facilities and users should stop using the affected instruments immediately. Integrated Medical Systems Inc is the recalling firm responsible for managing this recall. Users should contact the firm for instructions on how to return or replace the devices.
The recalled product
- Product
- Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope
- Manufacturer
- Integrated Medical Systems Inc
- Category
- Medical Device — Endoscope
- Affected units
- 5
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 (5)
- Serial Numbers: 2123053
- 2337714
- 2338700
- 2337727
- 2112612
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
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See all →- HighOlympus Video Gastroscope Recall Due to Internal Coil Detachment Risk
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- HighOlympus Video Colonoscopes Recalled Due to Internal Coil Detachment Risk
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- HighOlympus Video Gastroscope Recall Due to Internal Coil Detachment Risk
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