Auris Health Recalls MONARCH Bronchoscopy Platform Due to Software Malfunction
Auris Health, Inc. has issued a voluntary recall for 173 MONARCH Bronchoscopy Platforms due to a software issue that could cause unexpected robotic arm movement toward the patient.
What Happened
Auris Health, Inc. has initiated a voluntary recall of its MONARCH Platform used for bronchoscopy. The recall is driven by a software defect: if the application restarts after the patient-side selection is made but before the bronchoscope is loaded, the system re-initializes to a “patient-left” position. If the operator had previously selected the “patient-right” position, this software reset can lead to unanticipated robotic arm movement toward the patient’s left side.
Which Products Are Affected
A total of 173 units are affected by this recall. The specific products include:
- Product Name: MONARCH Platform, Bronchoscopy
- Catalog Numbers: MON-000005-01, MON-000005-01R, MON-000006, MON-000006-RFB, MON-000008
- Software Versions: 2.2.2, 2.2.3, 2.2.4, 2.2.5, and 4.1.1
- UDI-DI: 10810068810803, 10810068810988
- Serial Numbers: 173 specific serial numbers are included in the recall (e.g., 110024, 120088, 120057, 120046, 120058, and others listed in the official report).
This recall affects distribution in Canada, China, Hong Kong, and the following U.S. states: AL, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OR, PA, SC, SD, TN, TX, VA, VT, WA, WI, and WV.
What You Should Do
This is a firm-initiated voluntary recall. Healthcare providers and facilities utilizing the MONARCH Platform should verify if their equipment is running the affected software versions (2.2.2 through 2.2.5 or 4.1.1). Users should follow any specific corrective instructions provided by Auris Health, Inc. regarding software updates or operational workarounds to prevent unanticipated arm movement.
Why This Matters
The software error creates a risk of unanticipated robotic arm positioning. This movement may result in the robotic arm making physical contact with the patient or the endotracheal tube, potentially compromising patient safety during a procedure.
Source
Information provided by the FDA under Recall Number Z-1383-2026.
Source: FDA Official Notice