Auris Health Recalls MONARCH Bronchoscopy Platform Due to Software Malfunction
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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 this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
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.
Original source: FDA Official Notice ↗
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