PlainRecalls
FDA Devices Moderate Class II Ongoing

Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)

Reported: February 7, 2024 Initiated: December 8, 2023 #Z-0860-2024

Product Description

Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)

Reason for Recall

Loss of connectivity between the FlexArm and the Table due to a software issue.

Details

Units 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.
Location
Best

Frequently Asked Questions

What product was recalled?
Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12). Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Units affected: 28 systems (9 US, 1 Canada, 18 ROW).
Why was this product recalled?
Loss of connectivity between the FlexArm and the Table due to a software issue.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 7, 2024. Severity: Moderate. Recall number: Z-0860-2024.