Olympus Pediatric Colonoscope Recall Due to Internal Coil Detachment Risk
Integrated Medical Systems is recalling 190 Olympus PCF-H180AL pediatric 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 involves a medical device with a mechanical defect that could impair function during a procedure, representing a risk-of-harm product where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Integrated Medical Systems Inc is recalling 190 units of the Olympus Model No. PCF-H180AL flexible scope, large diameter, video pediatric colonoscope. The recall was initiated 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. This failure may result in the angulation mechanism not operating as intended.
The affected instruments were distributed nationwide in the United States and in Australia. The recall covers specific serial numbers listed in the official FDA notice. No illnesses or injuries have been reported in the source text.
Healthcare providers should stop using the affected devices and contact Integrated Medical Systems Inc for instructions on repair or replacement. Consumers should not use these devices if they are in their possession and should contact the manufacturer for guidance.
The recalled product
- Product
- Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope
- Manufacturer
- Integrated Medical Systems Inc
- Category
- Medical Device — Endoscope
- Affected units
- 190
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: 2005030
- 2800270
- 2007268
- 2802306
- 2802294
- 2108696
- 2801707
- 2006928
- 2201349
- 2904573
- 2108936
- 2006513
- 2107568
- 2801235
- 2800468
- 2200301
- 2006896
- 2802237
- 2802245
- 2109496
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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