FDA-Device2022-06-22Class II
Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R
Hazard
Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases perforation in the urinary tract/renal pelvis.
Sold states
CA FL MA MD MI NJ OH PR WI
Affected count
4 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1264-2022Don't want to check this manually?
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