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 | |
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