Olympus Corporation of the Americas Recall 93575
Description: OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including female reproductive organs.
Olympus Corporation of the Americas Recall 93575 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0644-2024 |
| Event ID | 93575 |
| Event Description | OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including female reproductive organs. |
| Product Type | Devices |
| Distribution | Nationwide |
| Quantity | 1403 units US |
| Recall Reason | Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes |
| Device Classification | 20240117 |
| Device Code Info | UDI-DI: 04953170310355 All Serial Numbers |
| Center Classification Date | 20240105 |
| Recall Initiation Date | 20231120 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | Letter |
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