Recall Z-1383-2026 · EOQ Bronchoscope (Flexible Or Rigid)
Auris Health, Inc
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
| Date | Feb 17, 2026 (initiated Jan 21, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| Action | 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 |
| Quantity | 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, VT, MD and the countries of Hong Kong, China, Canada. |
| FDA record | Open on fda.gov |