Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
FDA Recall Z-0450-2024 · Posted 2023-12-01
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Recalling FirmAURIS HEALTH INC
Recall StatusOpen, Classified
Product CodeEOQ
Date Initiated2023-10-18
Product Quantity110 units In total
Reason for Recall
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
Firm 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].
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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