FDA-Device2026-02-25Class IIPROCESSING DEFECT

Auris Health MONARCH Platform bronchoscopy device recalled for software positioning error

OTHERNationwide distributionMedical devices

What this means

The MONARCH Platform bronchoscopy device has a software issue that can cause the robotic arm to move unexpectedly. If the application restarts after you select a position but before loading the bronchoscope, the system may reset to the left side even if you selected right, potentially causing the arm to contact the patient or breathing tube.

Check if your MONARCH Platform matches one of the affected serial numbers listed in the FDA notice
Do not use affected devices until you receive updated software from Auris Health
Contact Auris Health or the FDA with questions about your device's status

The agency's original wording

Hazard

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

Worldwide - US Nationwide distribution in the states of MN, FL, NJ, NY, VA, WI, AZ, AL, MS, LA, MI, MA, MT, PA, WV, GA, DE, TX, CA, OH, IN, SC, CT, ND, MO, DC, IL, NE, ID, WA, NC, TN, OR, CO, SD, NM, VT, MD and the countries of Hong Kong, China, Canada.

Affected count

173

Manufactured in

5490 Great America Pkwy, Santa Clara, CA, United States

Products

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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1383-2026

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