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
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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