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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Philips Breast and Interventional MRI Coils Recalled for Patient Injury Risk

Agency Publication Date: November 25, 2024
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Summary

Philips North America Llc is recalling approximately 5,231 units of various breast and interventional MRI coils across multiple model lines, including Achieva, dS Breast, Mammotrak, and SENSE. The recall was initiated because of a potential safety issue where patients may be harmed while being prepared for or during an MRI scan. Philips has notified affected healthcare facilities by letter to ensure these devices are not used while the issue is being addressed.

Risk

The affected MRI coils may pose a risk of injury to patients during clinical preparation or while a scan is in progress. Although no specific injury counts were reported in the recall notice, the mechanical or safety failure of these components during a scan could lead to physical harm.

What You Should Do

  1. This recall affects several models of Philips MRI coils, including Achieva TX Interventional 3.0T, dS Breast (1.5T and 3.0T versions), Mammotrak Diagnostic and Interventional coils, and SENSE Breast Coils.
  2. Identify if your device is affected by checking the model (REF) number and serial number on the device label. Affected model numbers include 453530264711, 453530280721, 453530280731, 453530280881, 453530280891, 453530228872, 453530228882, 453530228911, 453530228891, 453530083951, 453530089302, 453530054571, and 453530264791. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Achieva TX Interventional Coil 3.0T
Variants: 3.0T
Model / REF:
453530264711
Serial Numbers (197):
171
318
274
333
116
120
169
177
449
430
280
460
301
287
539
545
182
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
UDI:
00884838066175

REF: 453530264711

Product: dS Breast 16ch 1.5T
Variants: 1.5T, 16-channel
Model / REF:
453530280721
453530280723
459801290511
459801290514
459801729882
Serial Numbers (361):
482
508
119
40
318
394
443
41
286
120
264
412
426
457
476
342
154
319
368
409
176
35
265
416
392
437
493
529
500
526
517
531
533
276
430
509
333
356
370
445
510
53
125
117
268
174
175
282
310
452
UDI:
00884838066854
00884838086425
00884838118393

REFs: 453530280721, 453530280723, 459801290511, 459801290514, 459801729882

Product: dS Breast 16ch 3.0T
Variants: 3.0T, 16-channel
Model / REF:
453530280731
459801290741
459801290744
459801729891
459801729892
Serial Numbers (440):
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
UDI:
00884838065840
00884838086197
00884838098381
00884838118041

REFs: 453530280731, 459801290741, 459801290744, 459801729891, 459801729892

Product: dS Breast 7ch 1.5T
Variants: 1.5T, 7-channel
Model / REF:
453530280881
453530280882
459801290431
459801290432
Serial Numbers (1026):
507
648
409
133
596
421
613
68
121
132
757
787
622
538
687
139
357
806
838
555
615
754
813
525
70
1755
518
594
628
662
502
653
575
629
473
281
335
367
364
567
1672
1683
740
144
1673
561
1655
445
435
1725
UDI:
00884838066847
00884838086111

REFs: 453530280881, 453530280882, 459801290431, 459801290432

Product: dS Breast 7ch 3.0T
Variants: 3.0T, 7-channel
Model / REF:
453530280891
453530280892
459801290711
459801290712
459801729911
459801729912
459801729913
Serial Numbers (888):
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
UDI:
00884838066168
00884838086173
00884838098404
00884838107953
00884838118294

REFs: 453530280891, 453530280892, 459801290711, 459801290712, 459801729911, 459801729912, 459801729913

Product: Mammotrak Diagnostic Coil 1.5T
Variants: 1.5T
Model / REF:
453530228872
Serial Numbers:
79
124
71
179
182
45
43
178
171
181
53
40
52
69
187
95
UDI:
00884838066762

REF: 453530228872

Product: Mammotrak Interventional Coil 1.5T
Variants: 1.5T
Model / REF:
453530228882
Serial Numbers:
69
82
143
64
77
87
76
81
134
124
141
103
135
138
73
72
131
UDI:
00884838066779

REF: 453530228882

Product: Mammotrak Diagnostic Coil 3.0T
Variants: 3.0T
Model / REF:
453530228911
Serial Numbers:
91
130
80
53
90
11
58
25
51
4
67
34
UDI:
00884838066786

REF: 453530228911

Product: Mammotrak Interventional Coil 3.0T
Variants: 3.0T
Model / REF:
453530228891
Serial Numbers:
73
96
58
95
119
26
16
56
94
38
28
66
135
120
2
76
UDI:
00884838065857

REF: 453530228891

Product: SENSE Breast Coil
Model / REF:
453530083951
Serial Numbers (370):
36987
36587
36690
36898
37009
36637
37129
37140
36957
36549
36548
36547
36893
36678
36736
36743
36744
36763
36770
36882
36897
36938
36939
37012
36585
36622
36618
36639
36635
36650
36648
36732
36681
36676
36769
36861
36885
36878
36883
36890
36894
36950
36941
36994
37000
36998
36993
37130
37159
37160
UDI:
00884838066588

REF: 453530083951

Product: SENSE Breast Coil 3.0T 7ch
Variants: 3.0T, 7-channel
Model / REF:
453530089302
Serial Numbers:
16
7
22
52
UDI:
00884838065413

REF: 453530089302

Product: ST SENSE Breast Coil
Model / REF:
453530054571
Serial Numbers (71):
36577
36597
36664
36706
36540
36604
36590
36670
36671
36704
36710
36712
36524
36555
36519
36521
36570
36573
36582
36580
36581
36603
36619
36663
36680
36711
36548
36576
36589
36606
36523
36567
36572
36601
36639
36661
36536
36588
36635
36631
36668
36613
36677
36530
36556
36575
36592
36632
36657
36669
UDI:
00884838066625

REF: 453530054571

Product: ST SENSE Breast Dx Coil
Variants: Diagnostic
Model / REF:
453530264791
Serial Numbers:
55
3
9
36
40
56
35
39
80
46
29
7
28
47
54
UDI:
00884838066823

REF: 453530264791

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95645
Status: Active
Manufacturer: Philips North America Llc
Sold By: Authorized Philips medical device distributors; Direct hospital sales
Manufactured In: United States
Units Affected: 13 products (5,231 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.