Recall Z-0860-2024 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
| Date | Jan 30, 2024 (initiated Dec 8, 2023) |
| Status | Open, Classified |
| Reason | Loss of connectivity between the FlexArm and the Table due to a software issue. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm issued an URGENT: MEDICAL DEVICE CORRECTION notification dated 12/08/2023 by certified mail to consignees. Consignees with affected devices are asked to utilize the provided workaround instructions. Additionally, consignees are asked to make all users aware of this recall notification and keep a copy of this notification with system documentation. Getinge Field Service Engineers will be dispatched to the field to install software updates to affected devices. Consignees with any questions can contact the recalling firm by phone at 1-800-722-9377. Consignees are asked to retur |
| Quantity | 28 systems (9 US, 1 Canada, 18 ROW) |
| Distribution | Worldwide - US Nationwide distribution in the states of CO, FL, IL, MS, NV and TX. The country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200917 | Azurion R2.1 Philips Medical Systems Nederland B.V., May 1, 2020 |