Z-0448-2024Class II

Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w

Name: Z-0448-2024 Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
Creator: Auris Health Inc
Published: 2023-10-18
License: https://open.fda.gov/license/

Auris Health, Inc / initiated 2023-10-18 / Open, Classified / root cause: software

FDA source

AURIS HEALTH INC began a recall of Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w on 2023-10-18. FDA classified it as Class II and gives the reason as "Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view". 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-0448-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-18
Posted: 2023-12-01
Recalling firm: Auris Health, Inc
Product: Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
Product code: EOQ Bronchoscope (Flexible Or Rigid)
Reason for recall: Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
Root cause tag: software
FDA root cause: Software design
Action: On October 19, 2023, Auris Health, Inc. issued an "URGENT: MEDICAL DEVICE CORRECTION" notification to affected consignees. Auris asked consignees to take the following actions: Should an image flip be detected in the Virtual Bronchoscope view while navigating toward the target, please perform the following steps to correct the image orientation: 1. Retract the MONARCH Bronchoscope outside the patient 2. Undock the MONARCH Bronchoscope from the arms 3. Clear any fault pop-up messages 4. Re-dock the MONARCH Bronchoscope to the arms 5. Re-initialize Navigation and proceed with the case 6. Please review this letter carefully and share it with anyone in your facility that needs to be informed. 7. Please complete all fields of the attached Acknowledgement Form confirming receipt of this notification and return the form via email to [email protected]. If you have any questions regarding this letter or need to report any customer complaints, please contact the MONARCH Support team at +1 (800) 434-0032 or via email at [email protected].
Quantity in commerce: 110 units In total
Distribution: US Distribution: AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OR, PA, SC, SD, TN, TX, WI & WV.
Product codes and lots: Software Version 2.2.4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0448-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0448-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0449-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0450-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01

Product code EOQ

K193534Class IIMonarch PlatformAuris Health, Inc. / cleared 2020-04-15

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)