Z-1383-2026Class II

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

Name: Z-1383-2026 MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006...
Creator: Auris Health, Inc
Published: 2026-01-21
License: https://open.fda.gov/license/

Auris Health, Inc / initiated 2026-01-21 / Open, Classified / root cause: software

FDA source

Auris Health, Inc began a recall of MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software on 2026-01-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1383-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-21
Posted: 2026-02-17
Recalling firm: Auris Health, Inc
Product: MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
Product code: EOQ Bronchoscope (Flexible Or Rigid)
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.
Root cause tag: software
FDA 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 [email protected] 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 [email protected] For Medical Information requests, visit firm's website at https://www.jnjmedtech.com/mir.
Quantity in commerce: 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.
Product codes and lots: Software versions: 2.2.2, 2.2.3, 2.2.4, 2.2.5, and 4.1.1. UDI-DI: 10810068810803, 10810068810988. Serial Numbers: 110024, 120088, 120057, 120046, 120058, 120015, 120160, 120068, 120081, 120056, 110028, 120128, 120017, 120089, 120075, 110016, 120031, 120169, 120113, 120168, 120055, 120014, 120060, 120174, 120195, 120026, 110038, 120124, 120194, 110027, 110035, 120123, 120091, 120007, 110022, 120006, 120152, 120004, 120120, 120041, 120106, 110034, 120126, 120082, 120151, 120051, 120020, 120153, 120193, 120170, 120108, 120037, 120074, 120199, 120130, 120095, 110026, 120096, 120009, 120111, 120022, 120054, 120163, 110045, 120027, 110039, 120090, 120141, 120072, 120155, 110049, 120143, 110047, 120125, 120052, 110052, 120100, 120050, 120098, 120045, 120131, 110020, 110030, 110032, 110021, 120013, 120105, 120136, 120192, 110017, 120029, 120139, 110031, 120137, 120053, 110029, 120028, 120034, 120085, 120019, 120049, 120209, 120144, 120161, 120001, 110033, 120145, 120127, 110046, 110043, 120011, 120070, 120076, 120134, 120117, 110025, 120077, 120149, 120191, 120102, 120002, 120156, 120010, 120171, 120003, 120023, 120146, 120188, 120043, 120071, 120042, 120196, 110051, 120065, 120172, 120116, 120150, 120066, 120166, 120033, 110013, 120079, 120008, 120086, 120032, 120073, 1806P1, 120197, 120080, 120078, 14, 120012, 110041, 120084, 120219, 110036, 120181, 120083, 120067, 120021, 120216, 120217, 120218, 120069, 120204, 120207, 120215, 120237, 120208, 120213, 120164, 120132, 120182

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1383-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1383-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-25	2026-02-17

Product code EOQ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)