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FDA (Device enforcement)Recalled 2023-12-08class ii

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)

Hazard

Loss of connectivity between the FlexArm and the Table due to a software issue.

Details from the source

Reason for recall: Loss of connectivity between the FlexArm and the Table due to a software issue. Distribution: Worldwide - US Nationwide distribution in the states of CO, FL, IL, MS, NV and TX. The country of Canada. Quantity: 28 systems (9 US, 1 Canada, 18 ROW) Lot/code info: (1) System Code: 722079; (1) UDI/DI: 00884838085268; (1) Serial Number: 1086, 1392, 703615, 1079, 743, 703456, 1248; (2) System Code: 722224; (2) UDI/DI: 00884838099258; (2) Serial Number: 1337, 1249, 1925, 1250, 468, 379, 647, 633, 1534, 887, 1349, 280, 969, 197, 1177, 455, 3, 2611, 2716, 606, 2025;

UPC codes

00884838085268, 00884838099258

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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