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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 MobiView and SmartPath MRI Upgrades Recalled for Imaging Errors

Agency Publication Date: May 16, 2025
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Summary

Philips North America LLC is recalling approximately 1,734 units of MobiView applications and various SmartPath upgrades used with MRI systems such as the Ingenia and MR series. The recall is due to potential alignment errors in the 'cross reference line' tool which helps clinicians align multiple images. No incidents or injuries have been reported in connection with this defect.

Risk

Alignment errors in imaging software can cause clinical reference lines to be displayed incorrectly. This poses a risk of diagnostic errors or incorrect patient positioning, which could lead to improper medical treatments or delays in care.

What You Should Do

  1. This recall affects the Philips MobiView application and numerous SmartPath dStream upgrades used in various MRI models including Ingenia, MR 5300, and MR 7700.
  2. Identification: Hospitals and clinical facilities should check their system software and model numbers to determine if their specific unit is included in the recall. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact Philips North America LLC or your authorized medical device distributor to arrange for a software correction, update, or replacement.
  4. For additional questions or to report a related issue, call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA).

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: SmartPath to dStream for 1.5T
Model / REF:
781260
782112
782146
Serial Numbers (80):
10044
10151
10164
10170
11000
11001
11062
11076
12009
18038
18663
18872
18938
20115
20164
20413
21011
21019
21062
21133
21249
21278
21477
21577
21583
21591
21880
21888
22157
22248
32049
32094
32099
32113
32142
32184
32217
32245
32286
32322
32334
32636
32845
39024
5479
5490
8057
8263
8305
8330
UDI:
00884838095076
00884838098886
00884838108691
Product: SmartPath to dStream for 3.0T
Model / REF:
782145
Serial Numbers:
17377
17385
34114
34208
38118
38170
38294
38313
38336
73002
73004
74004
UDI:
00884838095083
Product: SmartPath to dStream for XR and 3.0T
Model / REF:
781270
782113
Serial Numbers (55):
17283
17299
17321
17356
17357
17369
17378
17398
17416
17425
17473
17490
17499
17550
17564
17565
17569
17589
17590
17594
23026
24012
24023
24066
24075
24087
24090
24110
34107
34152
35043
35047
35056
38004
38023
38084
38089
38113
38120
38199
38202
38300
38366
17252
17258
17346
24039
24077
24146
34131
UDI:
00884838095083
00884838098909
Product: SmartPath to Ingenia Elition X
Model / REF:
782118
782144
Serial Numbers:
42072
42194
42306
71019
71025
71050
85661
85676
42062
42105
42323
42346
42441
71278
71504
71508
UDI:
00884838099746
00884838108677
Product: Upgrade to MR 7700
Model / REF:
782130
Serial Numbers:
42030
42066
42151
42211
42248
42376
45001
45007
45236
71613
71907
85643
85644
UDI:
00884838104402
Product: Evolution Upgrade 1.5T
Model / REF:
782116
782148
Serial Numbers (52):
41042
41047
41080
41139
41229
41287
41295
41327
41367
41424
41432
41433
41457
41568
70068
70284
70630
70696
70995
70996
81021
41011
41031
41244
41284
41334
41427
41464
41488
41523
41534
41547
70067
70289
70452
70454
70473
70590
70622
70644
70652
70742
70769
70803
70829
70966
70980
84102
84109
84368
UDI:
00884838099722
00884838108714
Product: Evolution Upgrade 3.0T
Model / REF:
782117
782143
Serial Numbers:
42023
42024
42078
42375
42402
42408
71348
85675
85687
85694
85705
42193
42225
42308
42320
42366
42415
71595
71815
71836
85649
85684
85688
85690
85695
85697
85699
85708
UDI:
00884838099739
00884838108660
Product: Ingenia 1.5T
Model / REF:
781315
781341
781396
782101
782115
782140
Serial Numbers (264):
61003
61005
61007
61014
61022
61023
61024
61029
61031
61033
61036
61045
61051
61052
61053
61054
61055
61057
61059
61062
61063
61076
61088
61093
61097
61101
61112
61124
70009
70042
70051
70056
70059
70075
70095
70104
70203
70223
70249
70257
70262
70300
70311
70346
70376
70381
70383
70427
70432
70439
UDI:
00884838099715
00884838055322
00884838009820
00884838098275
00884838099043
00884838108646
Product: Ingenia 1.5T S
Model / REF:
781347
Serial Numbers:
81042
81072
UDI:
00884838068421
Product: Ingenia 3.0T
Model / REF:
781342
781377
782103
Serial Numbers (193):
71029
71031
71038
71185
71193
71319
71322
71336
71355
71532
71556
71739
71796
85006
85066
85154
85191
85201
71001
71002
71006
71008
71026
71051
71061
71072
71088
71095
71101
71154
71163
71164
71184
71214
71231
71269
71288
71309
71311
71313
71335
71341
71344
71347
71366
71374
71384
71385
71412
71413
UDI:
00884838055339
00884838009813
00884838098299
Product: Ingenia Ambition S
Model / REF:
781359
782108
782139
Serial Numbers (152):
48001
48005
48009
48011
48014
48016
48023
48033
48034
48043
48045
48047
48122
48154
48160
48167
48173
48178
48179
48180
48242
48275
48285
48501
48503
48507
48524
48530
48537
48548
48549
48557
48564
48566
48568
48569
48571
48576
48577
48580
48582
48588
48589
48591
48595
48607
48608
48612
48614
48620
UDI:
00884838090057
00884838009813
00884838098299
Product: Ingenia 1.5T CX
Model / REF:
781262
Serial Numbers:
77059
77120
77158
77161
77178
77182
77191
77193
77203
UDI:
00884838068445
Product: Ingenia 3.0T CX
Model / REF:
781271
Serial Numbers:
78012
78016
78017
78018
78025
78028
78033
78035
78039
78042
78045
78050
78053
78060
78062
78082
78095
78100
78112
78122
78123
78133
78147
78148
78155
78175
78197
78199
78201
78202
78217
78229
78239
78259
78260
78286
78287
UDI:
00884838068452
Product: Ingenia Ambition X
Model / REF:
781356
782109
782138
Serial Numbers (300):
47002
47004
47011
47012
47018
47019
47020
47028
47029
47037
47049
47052
47057
47099
47173
47184
47187
47189
47200
47203
47204
47206
47211
47215
47222
47230
47231
47242
47245
47252
47258
47260
47268
47270
47274
47281
47283
47286
47290
47294
47297
47301
47304
47309
47312
47313
47314
47328
47342
47347
UDI:
00884838090040
00884838098350
00884838108622
Product: Ingenia Elition S
Model / REF:
781357
782106
782137
Serial Numbers (65):
46002
46004
46007
46012
46013
46015
46016
46018
46020
46021
46023
46025
46039
46049
46054
46068
46076
46082
46085
46092
46101
46203
46206
46207
46208
46209
46219
46220
46225
46235
46237
46241
46242
46243
46245
46258
46268
46269
46270
46286
46292
46326
64001
64002
64003
64004
64005
64007
64008
64009
UDI:
00884838088108
00884838098329
00884838108615
Product: Ingenia Elition X
Model / REF:
781358
782107
782136
Serial Numbers (198):
45010
45023
45028
45029
45032
45033
45034
45037
45040
45041
45043
45045
45046
45048
45049
45053
45066
45070
45072
45076
45087
45090
45091
45092
45093
45102
45105
45108
45115
45116
45119
45127
45136
45138
45140
45144
45147
45154
45156
45157
45162
45168
45181
45184
45189
45191
45194
45205
45222
45227
UDI:
00884838088115
00884838098336
00884838108608
Product: MR 5300
Model / REF:
782110
782152
Serial Numbers (186):
63007
63011
63022
63043
63047
63050
63051
63060
63074
63078
63079
63082
63085
63090
63095
63097
63100
63116
63121
63132
63136
63137
63142
63143
63144
63146
63150
63156
63160
63162
63166
63190
63202
63210
63222
63226
63228
63235
63238
63239
63244
63247
63258
63262
63263
63264
63265
63266
63267
63268
UDI:
00884838099364
00884838112841
Product: MR 7700
Model / REF:
782120
782153
Serial Numbers (72):
65000
65001
65002
65003
65004
65005
65007
65008
65009
65011
65012
65013
65014
65017
65018
65019
65020
65021
65023
65024
65025
65026
65027
65028
65029
65030
65031
65032
65034
65035
65037
65038
65039
65040
65041
65042
65050
65051
65056
65057
65059
65060
65061
65063
65064
65065
65066
68000
68001
68006
UDI:
00884838104112
00884838112858

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96889
Status: Active
Manufacturer: Philips North America Llc
Sold By: Authorized Medical Device Distributors; Direct Hospital Sales
Manufactured In: United States
Units Affected: 18 products (80 units (1 US, 79 OUS); 12 units (OUS only); 55 units (2 US, 53 OUS); 16 units (All OUS); 13 units (7 US, 6 OUS); 52 units (3 US, 49 OUS); 28 units (5 US, 23 OUS); 264 units (46 US, 218 OUS); 2 units (US Only); 193 units (36 US, 157 OUS); 152 units (25 US, 127 OUS); 9 units (OUS Only); 37 units (OUS Only); 300 units (81 US, 219 OUS); 65 units (6 US, 59 OUS); 198 units (25 US, 173 OUS); 186 units (2 US, 184 OUS); 72 units (6 US, 66 OUS))
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.

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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.