Auris Health, Inc recalls MONARCH Platform

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.

On 1/21/2026, correction notices were emailed to customers informing them of the following: Should a MONARCH application restart occur during procedure setup, please clear the fault message and then perform a full system restart. A full system restart will prevent this issue from occurring as it will require the user to perform patient-side selection and alignment again. Once the software update to address the issue is available, the firm will contact customers to schedule installation. Complete and return the acknowledgement form via email to MonarchSupport@its.jnj.com This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potential affected devices have been transferred. Please transfer this notice to other organizations on which this action has an impact. Maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective actions. If you have questions contact the firm at +1 (800) 434-0032 (toll-free within the United States), +1 (650) 264-6000 (Worldwide) or via email at MonarchSupport@its.jnj.com For Medical Information requests, visit firm's website at https://www.jnjmedtech.com/mir.

• FDA enforcement recordOfficial FDA database entry for Z-1383-2026
• FDA 510(k) clearance · K193534The device's official FDA premarket clearance record
• FDA 510(k) clearance · K211493The device's official FDA premarket clearance record
• FDA 510(k) clearance · K243219The device's official FDA premarket clearance record
• FDA device classification · EOQOfficial FDA classification for this device type
• CFR regulation · 21 CFR 874.4680The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Auris Health, IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.