Olympus colonoscope repair defect may impair imaging and suction function
Aizu Olympus is recalling 24 colonoscopes with defective repairs to the light guide connector. The defect may prevent proper imaging, reduce suction, and impair device cleaning, potentially exposing patients to contamination.
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: FDA Class II device with potential for patient infection from contaminated equipment due to inadequate reprocessing. No illnesses or injuries reported in the source, but the risk is significant given the infection potential from compromised device cleaning.
Plain-English summary
Aizu Olympus Co., Ltd. is recalling 24 CF-HQ190L EVIS EXERA III colonoscopes due to improper repairs to the light guide connector. The connector repair is missing adhesive to secure the suction channel mouthpiece, which may cause loss of image, decreased suction, or prevent effective device reprocessing.
The affected devices, identified by serial numbers 2635812 and 2416423, were distributed domestically to facilities in Florida, Kentucky, Massachusetts, New Jersey, New York, and Pennsylvania.
A colonoscope that cannot provide a clear image, maintain suction, or be properly cleaned poses risks to patients. Inadequate imaging may delay diagnosis and treatment, while improper device cleaning may expose patients to contaminated equipment and subsequent infection.
Healthcare facilities that received affected units should contact Aizu Olympus Co., Ltd. for replacement or repair instructions. Do not use affected devices until the issue is resolved.
The recalled product
- Product
- CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
- Manufacturer
- Aizu Olympus Co., Ltd.
- Category
- Medical Device — Colonoscope
- Hazard
- device-malfunction
- sterilization-failure
- infection-risk
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 (2)
- UDI-DI 04953170305115 Serial Numbers 2635812
- 2416423
Distribution
Distributed in 6 states:
- FL
- KY
- MA
- NJ
- NY
- PA
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