Monarch Platform, Bronchoscopy, Catalog Numbers: Mon-000005-01 , Mon-000005-01r , Mon-000006 , Mon-000006-rfb, Mon-000008 With Software

Recall Summary The MONARCH Platform bronchoscopy system (specific catalog numbers listed) is being recalled due to a software issue that can cause the robotic arm to move to an unexpected position during procedures. If the application restarts after a doctor selects the right-side position but before the bronchoscope is loaded, the system may reset to the left-side position, potentially causing the robotic arm to contact the patient or breathing tube. This recall affects the MONARCH Platform bronchoscopy devices manufactured by Auris Health, Inc.

Recalling firm

Auris Health, Inc

Product

MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software

Reason

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.

Classification

Class II

Category

consumer product recall

Country

United States

Agency

FDA-DEVICES

Recall date

2026-01-21

Status

Open, Classified

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/674f8600-7f54-4072-b49d-eea928494ff2