Olympus Pediatric Colonoscope Recalled for Potential Internal Coil Detachment
Integrated Medical Systems Inc. is recalling one Olympus PCF-H190L video pediatric colonoscope because excessive pressure may cause the internal coil pipe assembly 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 involves a risk-of-harm product where the defect (detached coil pipe) could prevent the device from operating as intended, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Integrated Medical Systems Inc. is recalling one unit of the Olympus Model No. PCF-H190L flexible scope, large diameter, video pediatric colonoscope. The recall involves a specific instrument with Serial Number 2303917.
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.
The affected instrument was distributed in the United States (nationwide) and in Australia. Users of this specific medical device should stop using the instrument and contact Integrated Medical Systems Inc. for further instructions.
The recalled product
- Product
- Olympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric colonoscope
- Manufacturer
- Integrated Medical Systems Inc
- Category
- Medical Device — Endoscope
- Affected units
- 1
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 (1)
- Serial Number 2303917
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
FDA (Devices) · 2016-03-02
- HighOlympus CF-Q160L Video Colonoscopes Recalled for Detached Internal Coil Pipe Assembly
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- HighOlympus Video Colonoscopes Recalled Due to Internal Coil Detachment Risk
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- 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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