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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2341-2023
Event ID92633
Event DescriptionTracheal 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 TypeDevices
DistributionNationwide
Quantity686 units
Recall ReasonRevised 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 Classification20230816
Device Code InfoUDI-DI: 04953170051098 All serial numbers
Center Classification Date20230804
Recall Initiation Date20230526
Recalling FirmOlympus Corporation of the Americas
Initial Notification Letter
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