Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MONARCH Platform Recalled by Auris Health, Inc Due to Device for bronchoscopic visualization, patient airway access has...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Auris Health, Inc directly.
Affected Products
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
Quantity: 173
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Auris Health, Inc
Auris Health, Inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report