medical Class II Updated 2023-12-06

Aizu Olympus Co., Ltd. recalls GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

Recalled Product

GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

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 04953170305290 Serial Numbers 2515895, 2312905, 2628532
View official government recall

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