GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
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.
Domestic distribution to FL, KY, MA, NJ, NY, and PA
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0417-2024