FDA-Device2024-02-14Class II
Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water. The MAJ-2318 water filter is compatible with OER-ELITE and OER-MINI.
Olympus Corporation of the Americas
Hazard
Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used for reprocessing. This may expose a patient to a potentially contaminated device, presenting a risk of infection or sepsis.
Sold states
Domestic US distribution nationwide.
Affected count
877 MAJ-2318, 119 OER-Elite, 3 OER-MINI
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water. The MAJ-2318 water filter is compatible with OER-ELITE and OER-MINI.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1009-2024Don't want to check this manually?
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