Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w
- Company
- Auris Health Inc
- Recall Initiated
- October 18, 2023
- Posted
- December 1, 2023
- Recall Number
- Z-0449-2024
- Quantity
- 110 units In total
- Firm Location
- Redwood City, CA
Reason for Recall
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
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 / Code Info
Software version 2.2.4
Root Cause
Software design
Action Taken
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.