AURIS HEALTH INC Recall 93320
Description: Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
AURIS HEALTH INC Recall 93320 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0450-2024 |
| Event ID | 93320 |
| Event Description | Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w |
| Product Type | Devices |
| 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. |
| Quantity | 110 units In total |
| Recall Reason | Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view. |
| Device Classification | 20231213 |
| Device Code Info | Software version 2.2.4 |
| Center Classification Date | 20231201 |
| Recall Initiation Date | 20231018 |
| Recalling Firm | AURIS HEALTH INC |
| Initial Notification | |
| Similar To |