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.
Sold states
Worldwide - US Nationwide distribution in the states of CO, FL, IL, MS, NV and TX. The country of Canada.
Affected count
28 systems (9 US, 1 Canada, 18 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-0860-2024Don't want to check this manually?
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