FDA has not published a risk classification for this recall yet.
- Recall #:
- 98108
- Lot/product code:
- 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;
- Recalling firm:
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.