Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
FDA device recall Z-0860-2024 · posted 2024-01-30 · Open, Classified
Recall details
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Reason for recall
- Loss of connectivity between the FlexArm and the Table due to a software issue.
- Action taken
- 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 return the provided response form to the recalling firm at ITG_Recalls@philips.com.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 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.
- Date initiated
- 2023-12-08
- Date posted
- 2024-01-30
- Location
- Best, Netherlands
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Azurion R2.1 (K200917) | Philips Medical Systems Nederland B.V. | 2020-05-01 |