medical Class II Updated 2022-06-29

Olympus Corporation of the Americas recalls EVIS EXERA II Gastrointestinal Videoscope-indicated for use

Recalled Product

EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190

Hazard / Issue

Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber fits tighter on the GIF-HQ190 which would not meet the intended design specifications

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 04953170305276 Serial: 2269931, 2611873, 2613235, 2634251, 2634326, 2860721, 2961773 and 2962545
View official government recall

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