Olympus Video Colonoscope Recalled for Potential Internal Coil Detachment
Integrated Medical Systems Inc is recalling one Olympus video colonoscope because excessive pressure may cause the internal coil pipe to detach, affecting angulation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 mechanical defect that could impair the device's function (angulation), representing a risk of harm where injury has not yet been reported.
Plain-English summary
Integrated Medical Systems Inc is recalling one Olympus Model No. XCF-Q160ALE flexible scope, large diameter, video colonoscope. The recall involves a single instrument with Serial Number 240T024.
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. This detachment may result in the angulation not operating as intended.
The product was distributed in the United States (nationwide) and in Australia. Users of the affected device should contact Integrated Medical Systems Inc for further instructions.
The recalled product
- Product
- Olympus, Model No. XCF-Q160ALE, flexible scope, large diameter, video 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 240T024
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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