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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.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Sedecal Mobile X-Ray Systems Recalled Due to Cleaning and Liquid Damage Risks

Agency Publication Date: October 23, 2025
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Summary

SEDECAL SA has issued a voluntary recall for 2,185 units of several mobile diagnostic X-ray systems, including AeroDR X30 and MobileDiagnost wDR 2.2 models. These devices are not water-resistant, and improper cleaning that allows liquid to enter the equipment housing can cause hardware damage or electrical issues. While no injuries have been reported, the firm is reminding clinical users to follow cleaning instructions exactly as outlined in the device manual to prevent malfunction. Users should contact their distributor or Sedecal to ensure they have the most up-to-date maintenance guidance.

Risk

If cleaning liquids or other fluids enter the device housing, it can cause internal damage that results in equipment failure or electrical hazards. This may lead to delays in patient diagnosis if the system becomes unavailable during clinical use.

What You Should Do

  1. This recall affects a wide range of Sedecal Mobile X-Ray Systems, including models SM-40HF, MobileDiagnost wDR, 40KWFX, and SM-32HF series variants.
  2. Identify if your device is affected by checking the model number and serial number on the manufacturer's label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Ensure all clinical staff are trained to clean the equipment strictly according to the instructions in the device manual to prevent liquid ingress.
  5. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional questions.

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: Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
Model / REF:
SM-40HF-B-D-KM
Serial Numbers (56):
G-81478
G81924
G84618
G87981
G88006
G88007
G87866
G84607
G86618
G88041
G87427
G80991
G-81936
G86688
G-82904
G86360
G84340
G86372
G81471
G86358
G86361
G87844
G87845
G85932
G86683
G84620
G84621
G85914
G87409
G87434
G84326
G84325
G-81925
G81923
G-81935
G84619
G-81934
G87426
G81002
G86686
G84339
G88042
G-82885
G-82887
G-82905
G84327
G85788
G85913
G85801
G86356
UDI:
08436046002593

Recall #: Z-0242-2026

Product: MobileDiagnost wDR 2.2; Mobile X-ray system
Model / REF:
REF 9890-010-89522
Serial Numbers (1197):
SN11000007
SN13000099
SN13000100
SN13000101
13000079
SN13000080
SN13000082
SN13000062
SN13000059
SN13000063
SN13000061
13000067
13000076
SN13000089
SN13000103
13000085
SN13000146
13000094
13000092
13000093
SN13000087
SN13000096
SN13000095
SN13000098
SN13000097
SN13000159
SN13000148
13000145
13000117
14000051
SN13000149
13000168
14000015
14000017
14000014
14000013
14000019
14000016
13000167
13000169
14000011
12000166
SN13000170
13000200
14000083
14000008
14000009
13000201
SN13000179
SN13000181
UDI:
08436046002357

Recall #: Z-0243-2026

Product: Model Number 40KWFX, Mobile X-ray system
Model / REF:
40KWFX
Serial Numbers (55):
G71453
G70953
G70930
G70537
G70757
G70797
G70275
G71257
G71983
G71975
G71467
G69702
G71440
G71329
G70244
G70955
G71462
G71320
G71451
G71466
G71335
G71446
G65260
G70951
G70814
G70931
G70942
G71991
G70261
G72080
G69697
G71978
G70938
G70247
G70250
G70947
G69706
G78917
G70943
G71343
G71345
G71346
G71258
G70527
G69551
G71442
G71977
G71987
G72083
G70242
UDI:
08436046002166

Recall #: Z-0244-2026

Product: Model Number 40KW-FX.899, Mobile X-ray system
Model / REF:
40KW-FX.899
Serial Numbers:
G72770
UDI:
08436046002166

Recall #: Z-0245-2026

Product: Model Number 40KWFXPLUS, Mobile X-ray system
Model / REF:
40KWFXPLUS
Serial Numbers (268):
G75176
G75504
G76697
G78126
G78025
G78715
G78307
G79071
G79091
G79193
G80165
G79928
G76507
G79861
G80255
G80202
G82594
G79057
G73017
G80154
G73616
G73471
G76479
G79615
G80179
G79467
G79827
G79840
G79877
G79926
G78011
G78726
G82574
G82638
G73651
G75438
G77820
G78050
G79426
G79634
G82590
G72392
G73520
G73524
G73627
G73642
G73653
G76730
G76888
G78212
UDI:
08436046002166

Recall #: Z-0246-2026

Product: Model Number 40KWFXPLUS.002, Mobile X-ray system
Model / REF:
40KWFXPLUS.002
Serial Numbers:
G73508
G73512
G71323
G72419
G78910
G72425
G83214
G70934
UDI:
08436046002166

Recall #: Z-0247-2026

Product: Model Number 40KWFXPLUS.004, Mobile X-ray system
Model / REF:
40KWFXPLUS.004
Serial Numbers:
G84489
G84504
G84589

Recall #: Z-0248-2026

Product: Model Number 40KWFXPLUS.005, Mobile X-ray system
Model / REF:
40KWFXPLUS.005
Serial Numbers:
G82576
G82871
G72391
G74872
G75722
G76782
G75035
G75723
G78884
G70532
G73630
G82077
UDI:
08436046002166

Recall #: Z-0249-2026

Product: Model Number 40KWFXPLUS.889, Mobile X-ray system
Model / REF:
40KWFXPLUS.889
Serial Numbers:
G77146
UDI:
08436046002166

Recall #: Z-0250-2026

Product: Model Number 40KWFXPLUS-710CW, Mobile X-ray system
Model / REF:
40KWFXPLUS-710CW
Serial Numbers:
G83204
G82622
G79677
G79194
G82129
G79632
G79837
G79924
G84490
G84640
G79699
G84605
UDI:
08436046002166

Recall #: Z-0251-2026

Product: Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system
Model / REF:
40KWFXPLUS-710CW.007
Serial Numbers:
G79192
G79195
G79212
G78205
G80256
G79692
G80053
UDI:
08436046002166

Recall #: Z-0252-2026

Product: Model Number 40KWMOBILE3.899, Mobile X-ray system
Model / REF:
40KWMOBILE3.899
Serial Numbers:
G64852

Recall #: Z-0253-2026

Product: Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system
Model / REF:
SM-20HF-Batt
Serial Numbers:
G23218
UDI:
08436046001091

Recall #: Z-0254-2026

Product: Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system
Model / REF:
SM-32HF-B-D-C
Serial Numbers:
G22915
G23633
G23828
G20560
G21319
G24800
G19667
G20347

Recall #: Z-0255-2026

Product: Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system
Model / REF:
SM-32HF-Batt
Serial Numbers:
G-33344
G29404
G29407
G30258
G30236
G63124
G60169
G26234
G26284
G25734
G38069
G-40590
G41143
G62020
G69393
G38082
G41163
G60166
G26244
G40196
G60461
G33309
UDI:
08436046001466

Recall #: Z-0256-2026

Product: Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray system
Model / REF:
SM-40HF-B-D-C
Serial Numbers:
G-33126
G31259
G35641
G35630
G35718
G37357
UDI:
08436046001510

Recall #: Z-0257-2026

Product: Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
Model / REF:
SM-40HF-B-D-C
Serial Numbers:
G25456
G25508
G25681
G25698
G25930
G27630
G27705
C-25709
G22652
G38643
G25673
G27664
G25708
G25689
G25457
C08042
G25641
G25663
G24234
G25517
G23833
G23945
G23954
G25458
G25528
G27497
G27497/584
G27651
G27689
G22586
G24220
G25755
G26016
G25529
G25396
G27792
C25709
G27701
G30684
UDI:
08436046001510

Recall #: Z-0258-2026

Product: Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
Model / REF:
SM-40HF-B-D-C
Serial Numbers:
G37528
UDI:
08436046001510

Recall #: Z-0259-2026

Product: Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
Model / REF:
SM-40HF-B-D-C
Serial Numbers:
G13768
G36626
G62493
G39518
G61725
G36211
G36281
G36573
G36581
G61368
G61880
G62037
G61367
G36227
UDI:
08436046001510

Recall #: Z-0260-2026

Product: Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray system
Model / REF:
SM-40HF-Batt
Serial Numbers:
G24948
G25512
C25673
25901
G25771
G26990
G25506
G22189
G30240
UDI:
08436046001114

Recall #: Z-0261-2026

Product: Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system
Model / REF:
SM-50HF-B-D-C
Serial Numbers:
151248
G23340
C05006-W
G22215
G27497/584
7034
G25402
G25910
UDI:
08436046001527

Recall #: Z-0262-2026

Product: Model Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray system
Model / REF:
SM-40HF-B-D-C
Serial Numbers:
G32487
31414
G35462
G32657
UDI:
08436046001510

Recall #: Z-0263-2026

Product: Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
Model / REF:
SM-40HF-B-D-C
Serial Numbers:
G31761
G30761
G32587
G32577
G31065
G33581
G30808
G30762
G29873
G30156
G30173
G30952
G30689
G33004
G30155
G30025
G35450
G35620
G30570
G31077
G29426
G33144
G29416
G30160
G30685
G33723
G30165

Recall #: Z-0264-2026

Product: Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
Model / REF:
SM-40HF-B-D-C
Serial Numbers:
G35462
G-32753
G35480
G33111
G33721
UDI:
08436046001510

Recall #: Z-0265-2026

Product: Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system
Model / REF:
SM-40HF-B-D-C
Serial Numbers:
G33585
UDI:
08436046001510

Recall #: Z-0266-2026

Product: Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system
Model / REF:
SM-40HF-B-D-C
Serial Numbers:
G-33103
G35422
G35504
G33127
G33646
UDI:
08436046001510

Recall #: Z-0267-2026

Product: Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray system
Model / REF:
SM-40HF-B-D-C
Serial Numbers:
G35524
G33711
UDI:
08436046001510

Recall #: Z-0268-2026

Product: Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
Model / REF:
SM-40HF-B-D-C
Serial Numbers:
G37587
UDI:
08436046001510

Recall #: Z-0269-2026

Product: Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system
Model / REF:
SM-40HF-B-D-C
Serial Numbers:
G35611
G37536
G37588
G37490
UDI:
08436046001510

Recall #: Z-0270-2026

Product: Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
Model / REF:
SM-40HF-B-D-C
Serial Numbers (180):
D11-40KW-F
G36689
G37293
G38198
G38657
G38385
G37687
G36643
G41114
G36137
G36761
G36272
G37188
G37359
G37456
G38178
G62012
G62059
G62892
G62943
G41083
G41100
G36217
G36537
G60066
G61812
G63322
G40016
G41203
G41222
G60061
G60063
G60064
G36732
G36751
G41119
G62480
G60418
G61707
G65172
G39639
G41104
G36526
G36601
G37129
G37209
G41244
G62015
G40024
G62828
UDI:
08436046001510

Recall #: Z-0271-2026

Product: Model Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray system
Model / REF:
SM-40HF-B-D-C
Serial Numbers:
G62066
UDI:
08436046001510

Recall #: Z-0272-2026

Product: Model Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray system
Model / REF:
SM-40HF-B-D-C
Serial Numbers:
G37158
G61698
G62863
G41192
G62814
G41098
G62566
G60400
G63392
G60406
UDI:
08436046001510

Recall #: Z-0273-2026

Product: Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system
Model / REF:
SM-40HF-B-D-C
Serial Numbers:
G39822
G62662
G62564
G61702
G60067
G38060
UDI:
08436046001510

Recall #: Z-0274-2026

Product: Model Number SM-40HF-B-D-C; 40KW CANON READY, Mobile X-ray system
Model / REF:
SM-40HF-B-D-C
Serial Numbers:
G41234
UDI:
08436046001510

Recall #: Z-0275-2026

Product: Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray system
Model / REF:
SM-40HF-B-D-C
Serial Numbers:
G36566
UDI:
08436046001510

Recall #: Z-0276-2026

Product: Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system
Model / REF:
SM-40HF-B-D-C
Serial Numbers (142):
G65281
G60407
G65682
G64582
G64789
G70752
G65384
G65418
G67250
G68470
G70521
G70524
G70913
G70914
G65166
G63507
G64205
G64842
G71447
G65175
G65382
G64793
G64798
G40226
G72434
G65554
G67230
G37280
G65174
G65558
15033R
G64271
G64713
G64849
G65168
G71272
G71309
G65284
G72955
G65043
G70919
G72429
G72789
G70928
G72776
G72766
G63409
G63418
G64893
G66907
UDI:
08436046001510

Recall #: Z-0277-2026

Product: Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system
Model / REF:
SM-40HF-B-D-C
Serial Numbers:
G39544
G62558
G71736
G40116
G65568
G65570
UDI:
08436046001510

Recall #: Z-0278-2026

Product: Model Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray system
Model / REF:
SM-40HF-B-D-C
Serial Numbers:
G64274
G40012
G64597
G70742
G72764
G61804
UDI:
08436046001510

Recall #: Z-0279-2026

Product: Model Number SM-40HF-B-D-C; 40KW70CDEMO.005, Mobile X-ray system
Model / REF:
SM-40HF-B-D-C
Serial Numbers:
G38652
G37633
G36042
G37641
608A
G36681
UDI:
08436046001510

Recall #: Z-0280-2026

Product: RADPRO MOBILE, Mobile X-ray system
Model / REF:
RADPRO MOBILE
Serial Numbers:
G30567
G31256
G32581
G30250
G28320
G30902
G29864
G35389
G30960
G33238
G31252
G33708
G30771
G33634
31412
31480
G33004
G33112
G33585
G31271
G31285
G32514
G32498
G35665
UDI:
08436046002166

Recall #: Z-0281-2026

Product: SED URS LP, Mobile X-ray system
Model / REF:
SED URS LP
Serial Numbers:
40116

Recall #: Z-0282-2026

Product: SHIMADZU RF.004, Mobile X-ray system
Model / REF:
SHIMADZU RF.004
Serial Numbers:
75723

Recall #: Z-0283-2026

Product: SM_40HF_B_D_VIR3, Mobile X-ray system
Model / REF:
SM_40HF_B_D_VIR3
Serial Numbers:
G86476
G86632
G86634
G85447
G86619
G85453
G85461
G86477
G86633
G87334
G87335
G87336
G87353
G86617
G87337
G85335
G85452
UDI:
08436046002166

Recall #: Z-0284-2026

Product: SM_40HF_B_D_VIR3.004, Mobile X-ray system
Model / REF:
SM_40HF_B_D_VIR3.004
Serial Numbers:
G73023
G87352
G80066
UDI:
08436046002166

Recall #: Z-0285-2026

Product: SM_40HF_BDC, Mobile X-ray system
Model / REF:
SM_40HF_BDC
Serial Numbers:
31526
UDI:
08436046001510

Recall #: Z-0286-2026

Product: SM_40HF_BDC3, Mobile X-ray system
Model / REF:
SM_40HF_BDC3
Serial Numbers:
G41213
UDI:
08436046001510

Recall #: Z-0287-2026

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97075
Status: Active
Manufacturer: SEDECAL SA
Sold By: Authorized medical equipment consignees
Manufactured In: Spain
Units Affected: 44 products (56 units; 1198 units; 55 units; 1 unit; 268 units; 8 units; 3 units; 12 units; 1 unit; 12 units; 7 units; 1 unit; 1 unit; 8 units; 22 units; 6 units; 39 units; 1 unit; 14 units; 9 units; 8 units; 4 units; 27 units; 5 units; 1 unit; 5 units; 2 units; 1 unit; 4 units; 181 units; 1 unit; 10 units; 6 units; 1 unit; 1 unit; 142 units; 6 units; 6 units; 6 units; 24 units; 17 units; 3 units; 1 unit; 1 unit)
Distributed To: California, Illinois, New Jersey

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.