Reported Feb 7, 2024 · Ongoing
Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
Philips Medical Systems Nederland B.v.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Veenpluis 4-6 · Best · N/A
Is this the product you have?
- Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
- Lot codes and dates
- (1)
- System Code
722079(1)
- UDI/DI
00884838085268(1)
- Serial Number
10058661361952124111697567033511135112282474863063870338581270334613031313893768929703638135770381093412027034617037061172703959703845703705(2)
- System Code
722224(2)
- UDI/DI
00884838099258(2)
- Serial Number
70 of 70 codes
539395278134730252370365726452724957816213883521655690555895216586160206482231177814317784779171718388204215076420361421157879212144146334757521873552576133242438786321147471254923097992283639
- Amount recalled
- 108 systems (14 US, 1 Canada, 93 ROW)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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