Olympus CF-140L Video Colonoscope Recalled Due to Internal Coil Detachment Risk
Integrated Medical Systems Inc is recalling nine Olympus CF-140L video colonoscopes because excessive pressure can cause the internal coil pipe assembly to detach, preventing proper 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 involves a medical device with a mechanical defect that could prevent the instrument from operating as intended during a procedure. This fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Integrated Medical Systems Inc is recalling nine Olympus, Model No. CF-140L, flexible scope, large diameter, 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. 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 specific serial numbers for the nine recalled units are 2127866, 2712435, 2914674, 2026893, 2916216, 2813792, 2228261, 2711888, and 2600329.
Healthcare providers and consumers should check their inventory for these specific serial numbers. If an affected instrument is found, it should be removed from service and returned to Integrated Medical Systems Inc for evaluation.
The recalled product
- Product
- Olympus, Model No. CF-140L, flexible scope, large diameter, video colonoscope
- Manufacturer
- Integrated Medical Systems Inc
- Category
- Medical Device — Endoscope
- Affected units
- 9
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 (9)
- Serial Numbers: 2127866
- 2712435
- 2914674
- 2026893
- 2916216
- 2813792
- 2228261
- 2711888
- 2600329
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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