medical Class II Updated 2024-12-04

Philips North America Llc recalls Achieva TX Interventional Coil 3.0T

Recalled Product

Achieva TX Interventional Coil 3.0T


Hazard / Issue

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: REF: 453530264711; UDI: 00884838066175; Serial No. 171, 318, 274, 333, 116, 120, 169, 177, 449, 430, 280, 460, 301, 287, 539, 460, 545, 182, 301, 502, 533, 109, 194, 178, 240, 198, 197, 223, 209, 204, 224, 93, 212, 341, 303, 237, 282, 298, 309, 268, 281, 297, 296, 312, 313, 326, 323, 325, 327, 345, 340, 350, 320, 346, 459, 358, 420, 495, 496, 323, 509, 468, 467, 522, 553, 535, 546, 538, 497, 543, 320, 560, 544, 550, 581, 554, 558, 593, 580, 603, 582, 561, 605, 576, 606, 588, 618, 586, 587, 574, 624, 601, 608, 623, 607, 613, 627, 630, 631, 229, 498, 542, 534, 579, 469, 532, 145, 231, 328, 410, 195, 245, 98, 164, 135, 196, 234, 84, 583, 125, 238, 429, 510, 255, 294, 199, 61, 45, 131, 57, 134, 57, 134, 123, 147, 133, 210, 283, 324, 497, 524, 115, 150, 291, 277, 118, 310, 247, 67, 130, 279, 137, 202, 206, 220, 241, 124, 246, 106, 156, 286, 41, 132, 118, 151, 138, 113, 107, 119, 142, 180, 203, 230, 227, 254, 319, 321, 290, 322, 321, 507, 536, 528, 530, 578, 507, 332, 364, 508, 288, 83, 122, 579, 105, 144, 235, 110, 94, 213, 278, 470, 537, 541, 602, 626, 82, 165, 329.
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