FDAFDA · Food and drugs·Recall number Z-0861-2024
Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
Published February 7, 2024 · Recall initiated: December 8, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Distributor
- Worldwide - US Nationwide distribution in the states of CO, FL, IL, MS, NV and TX. The country of Canada.
- Lot
- (1) System Code: 722079; (1) UDI/DI: 00884838085268; (1) Serial Number: 1005, 866, 1361, 952, 1241, 1169, 756, 703351, 1135, 1122, 824, 748, 630, 638, 703385, 812, 703346, 1303, 1313, 893, 768, 929, 703638, 1357, 703810, 934, 1202, 703461, 703706, 1172, 703959, 703845, 703705; (2) System Code: 722224; (2) UDI/DI: 00884838099258; (2) Serial Number: 539, 395, 278, 134, 730, 252, 370, 36, 572, 645, 272, 495, 781, 62, 1388, 352, 1655, 690, 555, 895, 2165, 861, 60, 20, 648, 2231, 1778, 1431, 778, 477, 917, 1718, 388, 2042, 150, 764, 2036, 1421, 157, 879, 212, 144, 1463, 347, 575, 2187, 355, 2576, 1332, 424, 387, 863, 211, 474, 712, 549, 2309, 799, 2283, 639, 1700, 2071, 537, 1589, 2208, 2057, 771, 772, 1216, 1667;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Netherlands
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