Olympus Corporation of the Americas Recall 92633
Description: Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display monitor and other ancillary equipment for management of Endotracheal Tube
Olympus Corporation of the Americas Recall 92633 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2341-2023 |
| Event ID | 92633 |
| Event Description | Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display monitor and other ancillary equipment for management of Endotracheal Tube |
| Product Type | Devices |
| Distribution | Nationwide |
| Quantity | 686 units |
| Recall Reason | Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible |
| Device Classification | 20230816 |
| Device Code Info | UDI-DI: 04953170051098 All serial numbers |
| Center Classification Date | 20230804 |
| Recall Initiation Date | 20230526 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | Letter |
| Similar To |