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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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Critical RiskFDA Device
Medical Devices/Diagnostic Equipment

Philips North America Llc: SENSE XL Torso Coils Recalled Due to Potential for Patient Burns

Agency Publication Date: June 27, 2024
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Summary

Philips North America has recalled approximately 1,050 SENSE XL Torso Coils used in MRI systems because the coils can overheat during medical imaging procedures. This defect has been identified in SENSE XL Torso Coil 1.5T, 3.0T, and 1.5T Mk2 models, which are used for torso and abdomen imaging in Philips MR Intera and Achieva systems. Overheating poses a significant risk of skin burns to patients while they are inside the MRI scanner. If you have a scheduled MRI or are a healthcare provider using these systems, please contact the manufacturer or your healthcare facility to verify the safety of the equipment.

Risk

The internal coils of the imaging device can heat up beyond safe temperatures during a scan, potentially causing thermal injuries or burns to the patient's skin upon contact or proximity.

What You Should Do

  1. Check your MRI equipment for SENSE XL Torso Coil models 1.5T, 3.0T, or 1.5T Mk2. You can identify affected units by searching for specific model numbers including 453567141882, 453567141883, 453567394941, 453567394942, 453567394943, 453567394945, 459801593182, 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, and 459801585212.
  2. Verify your serial number against the extensive list provided in the recall notice. High-risk serial numbers include, but are not limited to, 137, 141, 145, 147, 157, 18, 188, 19, 191, and 197 for the 1.5T model, and 40000, 100, 102, and 104 for the 3.0T model.
  3. Identify if your coil was included in a kit with model numbers 989603014351, 989603014352, 989603050641, or 989603050642.
  4. Healthcare providers should immediately stop using any torso coils identified as part of this recall to prevent patient injury.
  5. Contact Philips North America or your healthcare provider for further instructions regarding the inspection or replacement of the affected device.
  6. For additional questions or to report a problem, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Healthcare facility inspection and manufacturer consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: SENSE XL TORSO COIL 1.5T
Model / REF:
453567141882
453567141883
989603014351
989603014352
Lot Numbers (669):
137
141
145
147
157
18
188
19
191
197
251
291
301
320
356
360
364
366
371
39
394
40
408
418
428
434
446
464
468
470
471
472
557
95
124
352
303
328
315
443
2
412
215
358
300
427
175
421
300202352
432
Product: SENSE XL TORSO COIL 3.0T
Model / REF:
453567394941
453567394942
453567394943
453567394945
459801593182
989603050641
989603050642
Lot Numbers (429):
9
40000
100
102
104
144
192
84
98
42
301
228
761
87
880
814
0174R3
541
@001@0179R3
0141R3
0172R3
0189R3
0260R3
0265R3
0285R3
0358R3
116R3
121
127
149
152
153
158
165
176
180
213R3
216
220
224
235
237
263
265
267
273
274
286
294
298
Product: SENSE XL TORSO COIL 1.5T Mk2
Model / REF:
453567502281
453567502282
453567502283
453567502284
453567502285
453567502286
459801585212
Lot Numbers (459):
190
187
71
60
24
244
36
151
245
29
128
167
179
185
32
34
38
112
27
66
67
68
75
1025
1028
1029
1031
1036
1050
1052
1054
1064
1104
1106
111
1112
1131
1134
1135
115
1151
1152
1195
1205
1213
1217
1219
1350
1354
1359

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94786
Status: Active
Manufacturer: Philips North America Llc
Sold By: Authorized Medical Device Distributors; Direct Hospital Sales
Manufactured In: United States
Units Affected: 3 products (729 units; 307 units; 14 units)
Distributed To: Nationwide
Agency Last Updated: January 3, 2025

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.