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
6 of 6 products
Products covered by this recall # Barcodes Product as published 1 (1) System Code: 722079 2 00884838085268(1) UDI/DI: 00884838085268 3 (1) Serial Number: 1086, 1392, 703615, 1079, 743, 703456, 1248 4 (2) System Code: 722224 5 00884838099258(2) UDI/DI: 00884838099258 6 (2) Serial Number: 1337, 1249, 1925, 1250, 468, 379, 647, 633, 1534, 887, 1349, 280, 969, 197, 1177, 455, 3, 2611, 2716, 606, 2025 - Amount recalled
- 28 systems (9 US, 1 Canada, 18 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.
This product could cause temporary or reversible health problems — stop using it.
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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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