EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive t...
FDA Recall #Z-1132-2023 — Class II — December 21, 2022
Product Description
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
Reason for Recall
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
Recalling Firm
Olympus Corporation of the Americas — Center Valley, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1 unit
Distribution
US Nationwide distribution in the states of CA, FL, GA, NY, OR, VA.
Code Information
UDI: 04953170202315 Serial number 2807443
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated