Olympus Corporation of the Americas Recall 90195
Description: Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R
Olympus Corporation of the Americas Recall 90195 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1264-2022 |
Event ID | 90195 |
Event Description | Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R |
Product Type | Devices |
Distribution | CA FL MA MD MI NJ OH PR WI |
Quantity | 4 units |
Recall Reason | 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. |
Device Classification | 20220622 |
Device Code Info | UDI-DI: 04953170340833 Serial Number: 2836209F 2835978 2837272 2836299 |
Center Classification Date | 20220613 |
Recall Initiation Date | 20220420 |
Recalling Firm | Olympus Corporation of the Americas |
Initial Notification | |
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