Recall Z-0538-2025
Philips North America Llc · initiated November 4, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
dS Breast 16ch 3.0T
Codes / lots: REF: 453530280731, 459801290741, 459801290741, 459801290744, 459801729891, 459801729892; UDI: 00884838065840, 00884838086197, 00884838098381, 00884838118041; Serial No. 538, 170, 437, 14, 124, 189, 291, 194, 516, 412, 154, 271, 536, 122, 190, 151, 1, 353, 577, 479, 446, 502, 522, 481, 583, 578, 608, 592, 160, 393, 421, 422, 438, 432, 540, 526, 470, 580, 477, 483, 586, 521, 133, 50, 440, 223, 461, 537, 517, 448, 550, 539, 573, 621, 628, 588, 152, 447, 389, 458, 498, 495, 141, 147, 609, 533, 400, 567, 505, 560, 391, 557, 371, 425, 442, 456, 459, 534, 582, 546, 584, 365, 367, 370, 360, 369, 317, 382, 394, 387, 407, 416, 441, 443, 462, 455, 467, 463, 468, 464, 515, 520, 504, 505, 574, 576, 547, 593, 594, 601, 595, 602, 599, 618, 134, 145, 137, 104, 48, 164, 253, 270, 193, 187, 242, 191, 252, 250, 278, 249, 316, 290, 302, 329, 372, 303, 269, 332, 333, 339, 314, 305, 364, 418, 428, 616, 27, 265, 381, 551, 615, 607, 128, 128, 390, 406, 554, 366, 413, 488, 499, 579, 174, 172, 165, 263, 500, 414, 544, 427, 549, 378, 460, 317, 445, 523, 552, 310, 311, 306, 449, 606, 424, 435, 524, 465, 466, 501, 530, 532, 546, 555, 541, 575, 566, 469, 588, 627, 590, 603, 340, 242, 375, 377, 388, 409, 434…
Reason for recall
Potential safety issue where a patient may be harmed while preparing for or during a scan.
FDA-determined cause: Use error
Action taken
An URGENT MEDICAL DEVICE CORRECTION notice dated 10/31/24 was mailed to consignees. Consignees are to continue using affected systems in accordance with the intended use. When using the system follow section PRECAUTIONS, CAUTIONS & WARNINGS in the Instructions For Use (IFU). Consignees are to circulate the recall notice to all users for their awareness of the potential issue. The Recall Response Form is to be provided back to Philips MR within 30 days at Philips.Recall@philips.com. Customers with any questions are to contact their local Philips Representative.
Details
- Recall number
- Z-0538-2025
- Initiated
- November 4, 2024
- Posted by FDA
- November 25, 2024
- Product code
- MOS – Coil, Magnetic Resonance, Specialty
- Quantity
- 5,231 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- Philips North America Llc, Cambridge, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0536-2025 Class II | Achieva TX Interventional Coil 3.0TPotential safety issue where a patient may be harmed while preparing for or during a scan. | 11/04/2024Open, Classified |
| Z-0537-2025 Class II | dS Breast 16ch 1.5TPotential safety issue where a patient may be harmed while preparing for or during a scan. | 11/04/2024Open, Classified |
| Z-0539-2025 Class II | dS Breast 7ch 1.5TPotential safety issue where a patient may be harmed while preparing for or during a scan. | 11/04/2024Open, Classified |
| Z-0540-2025 Class II | dS Breast 7ch 3.0TPotential safety issue where a patient may be harmed while preparing for or during a scan. | 11/04/2024Open, Classified |
| Z-0541-2025 Class II | Mammotrak Diagnostic Coil 1.5TPotential safety issue where a patient may be harmed while preparing for or during a scan. | 11/04/2024Open, Classified |
| Z-0542-2025 Class II | Mammotrak Interventional Coil 1.5TPotential safety issue where a patient may be harmed while preparing for or during a scan. | 11/04/2024Open, Classified |
| Z-0543-2025 Class II | Mammotrak Diagnostic Coil 3.0TPotential safety issue where a patient may be harmed while preparing for or during a scan. | 11/04/2024Open, Classified |
| Z-0544-2025 Class II | Mammotrak Interventional Coil 3.0TPotential safety issue where a patient may be harmed while preparing for or during a scan. | 11/04/2024Open, Classified |
| Z-0545-2025 Class II | SENSE Breast CoilPotential safety issue where a patient may be harmed while preparing for or during a scan. | 11/04/2024Open, Classified |
| Z-0546-2025 Class II | SENSE Breast Coil 3.0T 7chPotential safety issue where a patient may be harmed while preparing for or during a scan. | 11/04/2024Open, Classified |
| Z-0547-2025 Class II | ST SENSE Breast CoilPotential safety issue where a patient may be harmed while preparing for or during a scan. | 11/04/2024Open, Classified |
| Z-0548-2025 Class II | ST SENSE Breast Dx CoilPotential safety issue where a patient may be harmed while preparing for or during a scan. | 11/04/2024Open, Classified |