MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-00000

FDA device recall Z-1383-2026 · posted 2026-02-17 · Open, Classified

Recall details

Recalling firm

Auris Health, Inc

Reason for recall

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.

Action taken

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.

Root cause

Software design

Status

Open, Classified

Product code

EOQ

Quantity affected

173

Distribution

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,

Date initiated

2026-01-21

Date posted

2026-02-17

Location

Santa Clara, CA

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