Auris Health MONARCH Platform Bronchoscopy System
Auris Health is recalling MONARCH Platform Bronchoscopy systems due to a software issue that may cause unexpected robotic arm repositioning and contact with the patient.
Contact Auris Health immediately if you operate or maintain a MONARCH Platform Bronchoscopy system with the affected catalog numbers. Do not use the device until you receive further instructions from the manufacturer regarding the software update or corrective action.
Why it was recalled
Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to patient-left position; and if right position was previously selected, this may lead to unanticipated robotic arm positioning toward patient-left, may result in contact with patient/endotracheal tube.
How to identify it
UPC 10810068810803 10810068810988
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
Where it was sold
Distributed nationwide.
Official source
Editorial summary by Recall Canary · last updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification