Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
Recall
- Recall Number
- Z-0450-2024
- Event Number
- 93320
- Firm
- AURIS HEALTH INC
- FEI Number
- 3014447948
- Product Code
- EOQ
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- October 18, 2023
- Posted
- December 1, 2023
- Address
- 150 Shoreline Dr, Redwood City, CA, 94065-1400
Description
Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
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].
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.
110 units In total