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
Auris Health is recalling MONARCH Platform Bronchoscopy systems (catalog numbers MON-000005-01, MON-000005-01R, MON-000006, MON-000006-RFB, MON-000008) due to a software issue that may cause the robotic arm to unexpectedly reposition toward the patient's left side if the application restarts after the operator selects the right position but before the bronchoscope is loaded, potentially resulting in contact with the patient or endotracheal tube.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
- UDI-DI
- 10810068810803, 10810068810988
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Editorial summary by Recall Canary · summary updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification