Olympus Video Colonoscopes Recalled Due to Internal Coil Detachment Risk
Integrated Medical Systems Inc is recalling 122 Olympus video colonoscopes because excessive pressure may cause the internal coil pipe assembly 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. The hazard involves a mechanical failure (detachment of the internal coil pipe) that could compromise the function of the medical device during a procedure, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Integrated Medical Systems Inc is recalling 122 Olympus Model No. PCF-Q180AL flexible 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 scope may not operate 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 documentation.
Healthcare providers and consumers should stop using the affected instruments immediately and contact Integrated Medical Systems Inc for instructions on repair or replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope
- Manufacturer
- Integrated Medical Systems Inc
- Category
- Medical Device — Endoscopes
- Affected units
- 122
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:2707306
- 2705876
- 2807674
- 2706579
- 2009538
- 2706717
- 2604531
- 2706710
- 2501499
- 2808113
- 2705777
- 2705730
- 2707016
- 2808779
- 2808777
- 2707125
- 2603799
- 2603795
- 2603779
- 2603825
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 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
- HighOlympus Video Gastroscope Recall Due to Internal Coil Detachment Risk
FDA (Devices) · 2016-03-02
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