FDA Medical Device Recalls (openFDA)
AURIS HEALTH INC: Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w
- Recall number
- Z-0449-2024
- Recalling firm
- AURIS HEALTH INC
- Product
- Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w
- Status
- Open, Classified
- Initiated
- 2023-10-18
- Posted
- 2023-12-01
- Terminated
- not on file
- Reason
- Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
- 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 MonarchSupport@its.jnj.com. 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 MonarchSupport@its.jnj.com.
- Quantity
- 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.
- Lot, serial or model codes
- Software version 2.2.4
- 510(k) numbers
- ["K193534"]
- PMA numbers
- not on file
- Product code
- EOQ
- Firm FEI
- 3014447948
- Firm city
- Redwood City
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28