FDA recall Z-0860-2024

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II · device

Product

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.

Distribution

Worldwide - US Nationwide distribution in the states of CO, FL, IL, MS, NV and TX. The country of Canada.

Key facts

Status
Ongoing
Initiation date
2023-12-08
Report date
2024-02-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Best, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0860-2024