Company: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Date of Enforcement Report: 1/30/2024
Class II
PRODUCT
Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
Recall Number:
Z-0860-2024
REASON:
Loss of connectivity between the FlexArm and the Table due to a software issue.
RECALLING FIRM/MANUFACTURER:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
VOLUME OF PRODUCT IN COMMERCE:
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.
