Home / Recalls / Olympus Corporation of the Americas / Z-0638-2022

Z-0638-2022 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
February 23, 2022
Initiation Date
December 13, 2021
Termination Date
December 26, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
295 units

Product Description

OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories

Reason for Recall

The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed instead of detergent for the cleaning cycle and detergent will be dispensed instead of alcohol for the alcohol cycle, resulting in a ineffective endoscope reprocessing and patient exposure to residual detergent

Distribution Pattern

Nationwide

Code Information

All serial numbers. UDI: 04953170404047

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