FDA-Device2023-08-16Class II
VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
Olympus Corporation of the Americas
Hazard
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
Sold states
Nationwide
Affected count
1433 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2340-2023Don't want to check this manually?
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