medical Class II Updated 2023-12-06

Aizu Olympus Co., Ltd. recalls CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE

Recalled Product

CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE

Hazard / Issue

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.

Issued by

FDA

Affected States: FL, KY, MA, NJ, NY, PA
Lot/Code Info: UDI-DI 04953170305115 Serial Numbers 2635812, 2416423
View official government recall

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