FDA-Device2023-02-22Class II

EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve) Model/Serial: CF-Q180AL

Olympus Corporation of the Americas
Hazard

A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error, potential for microbial contamination

Sold states
US Nationwide distribution in the states of CA, FL, GA, NY, OR, VA.
Affected count
1 unit
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve) Model/Serial: CF-Q180AL

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1132-2023

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