FDA-Device2023-12-06Class II
CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
Aizu Olympus Co., Ltd.
Hazard
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.
Sold states
Domestic distribution to FL, KY, MA, NJ, NY, and PA
Affected count
24 incorrectly repaired units
Manufactured in
3 Chome 1-1, Niiderakita, Aizuwakamatsu, Japan
Products
CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0415-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief