PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data. Issue 1 - System remains in continuous restart mode after the start-up. Issue 2 - Longitudinal Position Error Applicable only to systems with Poly-G3 frontal stand.
Philips Azurion system; Software Version Number: R3.1;
Software Version Number: R3.1; (1) Model Number: 722221; System Product Name: Azurion 3 M12; UDI-DI: 00884838099203; Serial Numbers: (2) Model Number: 722222; System Product Name: Azurion 3 M15; UDI-DI: 00884838099210; Serial Numbers: (3) Model Number: 722223; System Product Name: Azurion 7 M12; UDI-DI: 00884838099241; Serial Numbers: (4) Model Number: 722224; System Product Name: Azurion 7 M20; UDI-DI: 00884838099258; Serial Numbers: (5) Model Number: 722225; System Product Name: Azurion 7 B12; UDI-DI: 00884838099265; Serial Numbers: (6) Model Number: 722226; System Product Name: Azurion 7 B20; UDI-DI: 00884838099272; Serial Numbers: (7) Model Number: 722227; System Product Name: Azurion 5 M12; UDI-DI: 00884838099227; Serial Numbers: (8) Model Number: 722228; System Product Name: Azurion 5 M20; UDI-DI: 00884838099234; Serial Numbers: (9) Model Number: 722229; System Product Name: Azurion 3 M12; UDI-DI: 00884838116726; Serial Numbers: 5, 9, 32, 40, 35, 31, 33; (10) Model Number: 722230; System Product Name: Azurion 3 M15; UDI-DI: 00884838116733; Serial Numbers: 25, 54, 50, 52, 55, 30, 63, 60, 67; (11) Model Number: 722231; System Product Name: Azurion 5 M12; UDI-DI: 00884838116740; Serial Numbers: 62, 7, 8, 14, 17, 63, 6, 66, 59, 69, 56, 67, 48, 68, 80, 93, 87, 94, 81, 92, 18; (12) Model Number: 722232; System Product Name: Azurion 5 M20; UDI-DI: 00884838116757; Serial Numbers: 97, 39, 31, 100, 104, 93, 115, 113, 118, 119, 89, 54, 67, 7, 128, 86, 110, 132, 130, 131, 123, 137, 139, 117, 260; (13) Model Number: 722233; System Product Name: Azurion 7 M12; UDI-DI: 00884838116764; Serial Numbers: 239, 100, 233, 240, 176, 227, 223, 130, 161, 194, 243, 56, 193, 280, 75, 253, 156, 288, 72, 281, 304, 300, 105, 295, 312, 310, 285, 292, 290, 298, 297; (14) Model Number: 722234; System Product Name: Azurion 7 M20; UDI-DI: 00884838116771; Serial Numbers: 731, 727, 261, 473, 683, 722, 562, 750, 745, 766, 265, 701, 400, 310, 421, 314, 182, 579, 96, 763, 272, 612, 15, 844, 105, 702, 751, 384, 851, 869, 743, 337, 651, 455, 706, 312, 563, 709, 764, 871, 846, 278, 713, 802, 868, 277, 742, 184, 819, 759, 910, 928, 415, 414, 945, 961, 355, 933, 692, 920, 569, 939, 909, 553, 837, 856, 571, 756, 941, 570, 761, 981, 353, 888, 964, 820, 746, 736, 876, 599, 1017, 908, 487, 983, 495; (15) Model Number: 722235; System Product Name: Azurion 7 B12; UDI-DI: 00884838116788; Serial Numbers: 96, 79, 111, 100, 101, 38, 27, 92, 78, 118, 48, 131, 135, 22, 125, 103, 138, 139, 137; (16) Model Number: 722236; System Product Name: Azurion 7 B20; UDI-DI: 00884838116801; Serial Numbers: 241, 297, 198, 215, 305, 274, 299, 78, 279, 287, 318, 353, 324, 331, 293, 245, 314, 310, 317, 312, 77, 358, 206, 383, 380, 370, 377, 385, 405, 379, 328;
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →