FDA Device recall Z-0540-2025

dS Breast 7ch 3.0T

FDA Device
Class II
ongoing
Published 2024-12-04

On 2024-12-04 the FDA classified a Class II recall of dS Breast 7ch 3.0T by Philips North America, citing potential safety issue where a patient may be harmed while preparing for or during a scan.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0540-2025
Classification	Class II
Status	ongoing
Initiated	2024-11-04
Published	2024-12-04
Last updated	2026-09-13 11:57 UTC
Company	Philips North America
Distribution	US

Product

dS Breast 7ch 3.0T

Reason

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

Identifiers

code_info	REF: 453530280891, 453530280892, 459801290711, 459801290712, 459801729911, 459801729911, 459801729912, 459801729913; UD… REF: 453530280891, 453530280892, 459801290711, 459801290712, 459801729911, 459801729911, 459801729912, 459801729913; UDI-DI: 00884838066168, 00884838086173, 00884838098404, 00884838107953, 00884838118294; Serial No. 1050, 632, 709, 981, 944, 1060, 175, 703, 723, 1009, 102, 209, 227, 365, 514, 342, 509, 742, 753, 801, 819, 1013, 462, 903, 912, 833, 868, 843, 884, 892, 1002, 1038, 182, 170, 946, 980, 747, 219, 626, 907, 827, 840, 861, 854, 890, 871, 860, 850, 878, 891, 859, 894, 883, 889, 926, 863, 880, 909, 910, 988, 904, 888, 902, 966, 913, 929, 998, 935, 896, 928, 932, 943, 959, 958, 1051, 1041, 972, 1011, 982, 997, 978, 991, 992, 995, 987, 1062, 1008, 1004, 747, 999, 1029, 1044, 1014, 1063, 1036, 1057, 1058, 220, 297, 337, 339, 343, 543, 545, 615, 607, 602, 685, 623, 635, 619, 670, 496, 633, 229, 614, 628, 642, 624, 680, 717, 644, 676, 705, 682, 707, 792, 697, 776, 727, 704, 715, 713, 757, 805, 731, 770, 803, 754, 775, 778, 756, 751, 768, 689, 761, 794, 793, 799, 779, 773, 815, 814,

code_info

REF: 453530280891, 453530280892, 459801290711, 459801290712, 459801729911, 459801729911, 459801729912, 459801729913; UD…

REF: 453530280891, 453530280892, 459801290711, 459801290712, 459801729911, 459801729911, 459801729912, 459801729913; UDI-DI: 00884838066168, 00884838086173, 00884838098404, 00884838107953, 00884838118294; Serial No. 1050, 632, 709, 981, 944, 1060, 175, 703, 723, 1009, 102, 209, 227, 365, 514, 342, 509, 742, 753, 801, 819, 1013, 462, 903, 912, 833, 868, 843, 884, 892, 1002, 1038, 182, 170, 946, 980, 747, 219, 626, 907, 827, 840, 861, 854, 890, 871, 860, 850, 878, 891, 859, 894, 883, 889, 926, 863, 880, 909, 910, 988, 904, 888, 902, 966, 913, 929, 998, 935, 896, 928, 932, 943, 959, 958, 1051, 1041, 972, 1011, 982, 997, 978, 991, 992, 995, 987, 1062, 1008, 1004, 747, 999, 1029, 1044, 1014, 1063, 1036, 1057, 1058, 220, 297, 337, 339, 343, 543, 545, 615, 607, 602, 685, 623, 635, 619, 670, 496, 633, 229, 614, 628, 642, 624, 680, 717, 644, 676, 705, 682, 707, 792, 697, 776, 727, 704, 715, 713, 757, 805, 731, 770, 803, 754, 775, 778, 756, 751, 768, 689, 761, 794, 793, 799, 779, 773, 815, 814,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0540-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.