Auris Health recalls MONARCH Platform bronchoscopy devices with specific software versions due to potential unintended robotic arm movement during patient procedures, risking contact with patient or endotracheal tube.
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.
Auris Health is recalling specific MONARCH Platform bronchoscopy devices with certain software versions. The issue could cause the robotic arm to move unexpectedly toward the patient's left side, potentially touching the patient or endotracheal tube during procedures.
The software issue causes the device to re-initialize to the patient's left position after a restart. If the right position was previously selected, the robotic arm may move unexpectedly toward the patient's left side, potentially causing contact with the patient or endotracheal tube.
Medical professionals using the MONARCH Platform for bronchoscopy procedures are most at risk, particularly those with the recalled software versions. Patients undergoing these procedures may also be affected if the device malfunctions.
Check for the MONARCH Platform bronchoscopy devices with catalog numbers MON-000005-01, MON-000005-01R, MON-000006, or MON-000006-RFB. The affected devices have specific software versions: 2.2.2 through 2.2.5 and 4.1.1.
Verify the software version on your device; affected versions are 2.2.2 through 2.2.5 and 4.1.1.
Reach out to Auris Health directly for guidance on next steps if your device is affected.
The affected software versions are 2.2.2 through 2.2.5 and 4.1.1.
Check the catalog numbers: MON-000005-01, MON-000005-01R, MON-000006, or MON-000006-RFB. Affected devices have the specific software versions listed.
The recall record does not specify a fix or remedy; affected users should contact Auris Health for guidance.
We’ve drafted a message you can send Auris Health to request your refund or repair — edit it as you like.
Subject: Recall Z-1383-2026 — Auris Health Auris Health Hello, I own a Auris Health that is covered by recall Z-1383-2026 from Auris Health. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
