Product Safety Recalls

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Olympus Corporation of the Americas Recall 90195

Description: Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R

Olympus Corporation of the Americas Recall 90195 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1264-2022
Event ID90195
Event DescriptionOlympus URETERO-RENO FIBERSCOPE Model: URF-P6R
Product TypeDevices
DistributionCA FL MA MD MI NJ OH PR WI
Quantity4 units
Recall ReasonIncorrect 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.
Device Classification20220622
Device Code InfoUDI-DI: 04953170340833 Serial Number: 2836209F 2835978 2837272 2836299
Center Classification Date20220613
Recall Initiation Date20220420
Recalling FirmOlympus Corporation of the Americas
Initial Notification E-Mail
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