Home / Recalls / Olympus Corporation of the Americas / Z-1010-2019

Z-1010-2019 Class II Terminated

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
March 20, 2019
Initiation Date
December 17, 2018
Termination Date
November 18, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2

Product Description

Olympus TJF-Q180V Duodenoscope - 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.

Distribution Pattern

US Nationwide distribution in the states of CT, IL, MN, MO, and NC.

Code Information

Serial Number 2506043 and 2619818

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