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FDA-Device2026-02-25Class IIPROCESSING DEFECT

Auris Health MONARCH Platform bronchoscopy device recalled for software positioning error

Auris Health
OTHERNationwide distribution

Stop using affected Auris Health MONARCH devices

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
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.

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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