medical Class II Updated 2023-12-06

Aizu Olympus Co., Ltd. recalls PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE

Recalled Product

PCF-H190DL, 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 04953170363672 Serial Numbers 2942716, 2604497, 2502056
View official government recall

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