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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

Siemens MAGNETOM and Biograph MRI Systems Recalled for Helium Leak Risk

Agency Publication Date: September 30, 2025
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Summary

Siemens Medical Solutions USA, Inc. has issued a voluntary recall for approximately 1,796 Biograph and MAGNETOM imaging systems. This recall was initiated due to the potential for ice to block the magnet's venting system, which could prevent helium gas from escaping safely during a system quench. Because no specific remedy was provided in the announcement, users are advised to contact their healthcare provider or Siemens directly for further instructions.

Risk

If ice blockages prevent helium gas from venting safely during a quench, pressure can build up until the helium containment system ruptures. This could result in a helium leak into the scanning room, displacing oxygen and creating an asphyxiation hazard for patients and staff.

What You Should Do

  1. This recall involves various Siemens Biograph and MAGNETOM imaging systems, including the Biograph mMR, BIOGRAPH One, MAGNETOM Cima.X, Connectom.X, Lumina, Prisma, Skyra, Skyra fit, Skyra Fit BioMatrix, Spectra, Verio, Verio Dot, Verio Dot Upgrade, Vida, and Vida Fit.
  2. Identify your system by checking the model number and serial number printed on the device label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact Siemens Medical Solutions USA, Inc. or your distributor to arrange for a system inspection, replacement, or correction to ensure the magnet venting system is clear of ice blockages.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

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: Biograph mMR
Model / REF:
10433372
Serial Numbers:
151032
151057
51053
151034
51003
151021
51055
151013
51064
151044
51038
51006
51030
151004
51022
151049
51007
151045
51032
51057
51015
151025
51048
51062
51010
51051
UDI:
04056869006741
04056869245188

Additional serial number added 01/23/2026: 51007.

Product: BIOGRAPH One (DE)
Model / REF:
11689172
Serial Numbers:
238008
UDI:
4068151020472
Product: MAGNETOM Cima.X (DE)
Model / REF:
11647158
Serial Numbers:
213029
213006
213062
213043
213041
213034
213035
213028
213031
213018
213061
213005
213021
213022
213056
213030
213039
213025
213063
213057
213026
213020
UDI:
04056869975221
Product: MAGNETOM Connectom.X
Model / REF:
11371480
Serial Numbers:
237551
Product: MAGNETOM Lumina (DE)
Model / REF:
11344916
Serial Numbers (130):
196458
196591
196655
196355
196733
196668
196477
196343
196553
196519
196366
196782
196617
196684
196502
196539
196280
196626
196511
196643
196796
196551
196495
196741
196621
196611
196544
196724
196776
196752
196372
196350
196841
196252
196508
196332
196496
196753
196375
196738
196260
196470
196765
196334
196288
196409
196737
196286
196604
196446
UDI:
04056869230740
Product: MAGNETOM Prisma
Model / REF:
10849582
Serial Numbers (101):
166324
66104
166097
166024
166018
66109
66111
166114
166242
166268
166200
166047
66047
166292
166041
166007
166037
66112
166025
166003
66102
166254
166074
166281
166220
66027
166221
166321
166193
166012
166121
66053
166160
66094
166310
66028
166102
166034
166030
66106
166235
166273
166201
166345
166225
66044
66018
166006
166009
166295
UDI:
04056869006727
Product: MAGNETOM Skyra (DE)
Model / REF:
10432915
Serial Numbers (573):
45046
45115
45398
145760
145811
45549
45834
146099
146110
45047
146093
46066
45788
146082
45124
45185
45332
45466
145390
45732
45918
45380
46182
45735
45233
145735
145008
145473
145095
145664
45200
146098
146086
45805
45812
45397
46264
45499
45749
45289
46220
45369
45267
45253
45060
146103
45333
146123
46147
145721
UDI:
04056869006703
04056869006680

Additional serial numbers added 11/14/2025, 01/23/2026, and 2/25/2026.

Product: MAGNETOM Skyra fit
Model / REF:
10849580
Serial Numbers (55):
170068
170053
70022
170049
170018
170106
170109
170039
170066
170023
170030
170004
170016
170077
170058
170002
170050
170010
170019
70026
170056
170061
170105
170017
170041
70032
170111
170048
170101
170100
170060
170099
170036
170007
170001
170009
70020
170112
170113
170054
170047
170046
70023
70027
170110
170095
170075
170011
170081
170044
UDI:
04056869006710
04056869006680

Additional serial numbers added 2/25/2026 and 04/16/2026.

Product: MAGNETOM Skyra Fit BioMatrix
Model / REF:
11516217
Serial Numbers:
212087
212098
212088
212068
212081
212018
212041
212038
212047
212019
212037
212032
212049
212017
212064
212096
212065
212016
212023
212056
212054
212063
212051
212055
212021
212060
212011
212066
212074
212090
212034
212029
212097
212099
212039
212059
212030
212035
212036
UDI:
04056869299273
Product: MAGNETOM Spectra
Model / REF:
10837643
10655588
Serial Numbers:
72030
72023
56069
UDI:
04056869006802
04056869006796

Includes model numbers 10837643 and 10655588 (CN).

Product: MAGNETOM Verio
Model / REF:
10276755
Serial Numbers (152):
40649
40585
40781
40243
40408
40628
40848
40870
40783
40473
40240
40497
40564
40425
40778
40389
40340
40523
40582
40168
40291
40283
40201
40850
40331
40126
40744
40821
40433
40502
40179
40246
40273
40766
40753
40828
40737
40352
40313
40382
40670
40387
40631
40669
40131
40541
40466
40292
40375
40161

Additional serial numbers added between 11/14/2025 and 4/17/2026.

Product: MAGNETOM Verio Dot
Model / REF:
10684333
Serial Numbers (58):
60060
160040
160028
160021
60108
60121
160019
60091
160020
160043
60062
60061
160029
160038
60086
60126
60047
160036
160003
160042
160024
60092
160035
60102
160039
60112
160030
60099
160007
160001
160006
160009
160033
60053
60070
60101
60125
60085
60113
160027
160012
160016
160032
160013
160014
160018
160031
160011
160015
60054
UDI:
04056869006673

Additional serial number added 2/25/2026: 60113.

Product: MAGNETOM Verio Dot Upgrade
Model / REF:
10684334
Serial Numbers (78):
162012
162055
162039
162002
162014
162069
162083
162075
162028
162060
162035
162038
162016
62040
162036
162079
162054
162088
162071
162078
62032
62037
162077
162042
162025
162082
162085
162026
62027
162040
162032
162072
162037
162043
62014
162047
162023
62019
62050
162089
162061
62018
162004
162080
162013
162007
162049
162031
162009
162008
UDI:
04056869006680
Product: MAGNETOM Vida (DE)
Model / REF:
11060815
Serial Numbers (498):
176636
177211
175728
175685
175851
175768
177298
177295
176756
175754
177349
176757
177232
175935
176967
175741
177052
176060
176371
177012
177146
175770
176375
176122
176308
175669
176212
176755
176781
176302
176036
175766
176825
177151
176087
176771
177299
176451
177352
177354
176779
175870
175838
175692
177359
177119
175977
176037
177244
176686
UDI:
04056869039176
Product: MAGNETOM Vida Fit
Model / REF:
11410481
Serial Numbers:
202129
202025
202139
202016
202051
202055
202114
202119
202013
202050
202102
202160
202127
202071
202078
202123
202082
202107
202031
202110
202108
202101
202093
202104
202028
202026
202076
202142
202125
202155
202084
202151
202068
202135
202121
202006
202010
202011
202146
202145
UDI:
04056869245188

Additional serial number added on 01/23/2026: 202135

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97530
Status: Active
Manufacturer: Siemens Medical Solutions USA, Inc
Sold By: authorized medical distributors; specialty retailers
Manufactured In: United States
Units Affected: 15 products (27 units; 1 unit; 22 units; 1 unit; 130 units; 101 units; 586 units; 56 units; 39 units; 3 units; 154 units; 59 units; 78 units; 498 units; 41 units)
Distributed To: Nationwide
Agency Last Updated: April 17, 2026

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.