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Aizu Olympus Co., Ltd. recalls PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
Recalled December 6, 2023 · FDA recall Z-0419-2024 · Aizu Olympus
Hazard
Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection. · FDA Class II
Units
24 incorrectly repaired units
Sold at
Domestic distribution to FL, KY, MA, NJ, NY, and PA
Description
Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
Product
PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
Manufacturer(s)
Aizu Olympus Co., Ltd.
Made in
Japan
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →