Olympus GF-UCT180 Ultrasound Gastrovideoscope - Product Usage: These endoscopes are intended for ...
FDA Recall #Z-1007-2019 — Class II — December 17, 2018
Product Description
Olympus GF-UCT180 Ultrasound Gastrovideoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
Reason for Recall
The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair.
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
Distribution
US Nationwide distribution in the states of CT, IL, MN, MO, and NC.
Code Information
Serial Number 7621683
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated