Device product
Achieva TX Interventional Coil 3.0T
Z-0536-2025
Product summary
- Event
- Event 95645
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5,231 units
- Official record key
device-enforcement:Z-0536-2025
Official wording
Reason: Potential safety issue where a patient may be harmed while preparing for or during a scan.
Code information: 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.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Potential safety issue where a patient may be harmed while preparing for or during a scan.