FDA-Device2022-02-23Class II
OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories
Olympus Corporation of the Americas
Hazard
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
Sold states
Nationwide
Affected count
295 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0638-2022Don't want to check this manually?
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