AURIS HEALTH INC Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
Brand
AURIS HEALTH INC
Lot Codes / Batch Numbers
Software Version 2.2.4
Products Sold
Software Version 2.2.4
AURIS HEALTH INC is recalling Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w due to Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KY, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NY, NC, ND, OH, OR, PA, SC, SD, TN, TX, WV, WI, DC
Page updated: Jan 10, 2026