Recall Z-0448-2024 ยท EOQ Bronchoscope (Flexible Or Rigid)
AURIS HEALTH INC
Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
| Date | Dec 1, 2023 (initiated Oct 18, 2023) |
| Status | Open, Classified |
| 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193534 | Monarch Platform Auris Health, Inc., Apr 15, 2020 |