FDA-Device2024-02-07Class II
Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Hazard
Loss of connectivity between the FlexArm and the Table due to a software issue related to the date/time format. This connection issue leads to a loss of movement of the arm or table.
Sold states
Worldwide - US Nationwide distribution in the states of CO, FL, IL, MS, NV and TX. The country of Canada.
Affected count
108 systems (14 US, 1 Canada, 93 ROW)
Manufactured in
Veenpluis 4-6, Best, Netherlands
Products
Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0861-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief