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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 MR Systems Recalled for Gradient Coil Component Fire Risk

Agency Publication Date: July 30, 2025
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Summary

Philips North America is recalling 8,052 units of various Magnetic Resonance (MR) imaging systems, including models in the Achieva, Ingenia, and MR 5300 lines. The recall was initiated because components in the Gradient Coil of these systems can fail and act as a heat source. If these components overheat, they have the potential to produce smoke or cause a fire within the imaging environment. Consumers should contact their facility administrator or the manufacturer to arrange for an official system correction.

Risk

A component failure in the Gradient Coil can lead to excessive heat buildup during medical scans. This overheating creates a risk of smoke inhalation and fire, which could cause injury to patients or medical staff and damage clinical facilities.

What You Should Do

  1. This recall affects multiple Philips MR imaging systems, including models Achieva 3.0T, Achieva XR, Ingenia 1.5T/3.0T, MR 5300, MR 7700, and several Evolution and SmartPath upgrade kits.
  2. Identify if your system is affected by checking the model number (REF) and serial number on the device's identification label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device and contact Philips North America or your local distributor immediately to arrange for a technical correction, repair, or system assessment.
  4. Monitor the system for any unusual odors, smoke, or signs of overheating while awaiting a technician.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 if you have additional safety questions or have experienced an incident related to this failure.

Your Remedy Options

📋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 3.0T
Model / REF:
781177
781277
781278
781344
781345
Serial Numbers (459):
17008
17011
17017
17030
17035
17038
17039
17043
17049
17051
17056
17061
17072
17075
17079
17093
17094
17099
17114
17130
17134
17139
17142
17144
17146
17147
17149
17161
17167
17168
17170
17171
17178
17179
17182
17183
17185
17187
17189
17216
17217
17226
17233
17234
17235
17243
17251
17256
17270
17279
UDI:
00884838004139

Quantity: 460 units.

Product: Achieva XR
Model / REF:
781153
781253
Serial Numbers:
23003
23004
23005
23011
23014
23017
23020
23021
23028
23031
23035
23041
34039
35004
35006
35007
35011
35015
35016
35019
35020
35021
35022
35028
35035
35049
35050
35061
35063
35067
35068
35069
35070
35074
35075
35076
35081
35083
35084
35085

Quantity: 40 units.

Product: Evolution Upgrade 1.5T
Model / REF:
782116
782148
Serial Numbers (93):
41017
41024
41025
41041
41042
41047
41051
41080
41089
41130
41139
41143
41144
41179
41189
41196
41226
41229
41235
41286
41287
41295
41311
41327
41344
41349
41367
41413
41424
41432
41433
41457
41491
41497
41520
41527
41568
70068
70093
70099
70190
70202
70205
70260
70284
70589
70630
70696
70949
70995
UDI:
00884838099722
00884838108714

Quantity: 93 units.

Product: Evolution Upgrade 3.0T
Model / REF:
782117
782143
Serial Numbers:
42003
42023
42024
42029
42078
42217
42246
42375
42402
42408
71044
71348
71774
85146
85645
85663
85668
85675
85677
85680
85685
85687
85694
85698
85705
85713
3
42069
42193
42225
42308
42320
42366
42415
71595
71815
71836
85649
85651
85682
85683
85684
85688
85690
85695
85697
85699
85701
85708
85714
UDI:
00884838099739
00884838108660

Quantity: 50 units.

Product: Ingenia 1.5T
Model / REF:
781315
718641
781396
782101
782115
782140
Serial Numbers (6235):
61000
61001
61002
61003
61004
61005
61006
61007
61008
61009
61011
61013
61014
61015
61016
61017
61018
61019
61020
61022
61023
61024
61025
61026
61027
61028
61029
61030
61031
61032
61033
61034
61035
61036
61037
61038
61039
61040
61041
61042
61043
61044
61045
61046
61047
61049
61050
61051
61052
61053
UDI:
00884838099715
00884838055322
00884838009820
00884838098275
00884838099043
00884838108646
00884838068421
00884838055339
00884838009813
00884838098299
00884838068452
00884838098312
00884838090057
00884838098343
00884838108639
00884838090040
00884838098350
00884838108622
00884838088108
00884838098329
00884838108615
00884838088115
00884838098336
00884838104129
00884838108608
00884838099364
00884838112841
00884838104112
00884838112858
00884838108684
00884838095083
00884838098909
00884838105805
00884838099746
00884838108677
00884838104402

Aggregate listing for all Philips MR lines including Ingenia, MR 5300/7700, and SmartPath kits.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97172
Status: Active
Manufacturer: Philips North America
Sold By: hospitals; imaging centers; clinics
Manufactured In: United States
Units Affected: 19 products (460 units; 40 units; 93 units; 50 units; 2,279 units; 136 units; 1,467 units; 350 units; 611 units; 690 units; 242 units; 632 units; 1 unit; 551 units; 82 units; 15 units; 294 units; 33 units; 26 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 · 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.