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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens

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 Class 2 Device Recall Siemens see related information
Date Posted June 04, 2014
Recall Status1 Terminated on August 18, 2015
Recall Number Z-1717-2014
Recall Event ID 68312
510(K)Number K081722 
Product Classification System, x-ray, stationary - Product Code KPR
Product Siemens Ysio Systems

Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) ad emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio System is not meant for mammography. The Ysio uses an integrated or portable digital detector for generating diagnostic images by converting x-rays into electronic signals. Ysio is also designed to be used with conventional film/screen or Computed Radiography *CR) cassettes.
Code Information Model nos. 10281013,10281163

with serial nos. 30080
23071
20045
31072
22523
22776
22787
31137
23021
20034
20112
22775
22279
22283
22280
22875
22290
22576
22848
31060
31136
31064
31138
22326
23068
22288
22114
22714
21100
22960
23082
22169
22601
21065
21205
31017
31135
31040
21086
22972
30038
30047
23029
22538
22658
21088
21103
31120
21224
21221
21223
21085
31122
22597
22388
22391
20115
22104
22583
23097
22943
22942
22585
22781
21089
20093
20110
21066
22404
22796
22506
21031
30040
22119
22599
22844
22148
22880
21139
21006
20155
30055
30024
21114
21112
21122
31069
21185
30051
31078
30076
31012
22429
22190
31010
31011
22146
22527
22520
22126
22128
23138
31018
22836
23083
23036
22163
20089
20107
20088
20106
21052
22727
23098
22135
22737
22872
22542
22549
22551
22567
22500
31075
22449
30032
22350
31128
22389
31004
22984
30028
23020
31026
31134
21213
22247
22347
30078
22428
22137
22917
22873
31115
20167
31053
31081
21174
22029
22725
22724
31094
22286
31019
22093
22933
22920
22895
22681
22676
22682
22019
22020
21098
31077
31119
30062
31054
22080
31121
30050
21057
22833
22840
22955
31093
22058
31046
22931
22847
22852
22309
21101
22612
21120
21117
21116
21118
22367
22600
22946
30021
22655
22705
23016
22699
22192
22251
22899
31028
21091
31071
22928
22275
21092
22254
21037
21077
21076
22839
22117
22609
22543
22821
30029
23118
22838
22842
21200
21209
21203
20149
21163
22708
21172
21171
21173
22248
31067
31066
23053
30066
30067
30063
22789
22857
22055
22050
22038
22051
22056
22037
22060
22242
22071
22208
22073
22632
22683
22666
22541
22537
22364
23127
23129
20094
22132
22026
22027
22225
23024
23022
30052
23130
23132
22092
21115
22456
22441
22021
22730
22743
22851
21113
22175
31003
22584
20047
21194
22786
31117
31145
23018
23019
22166
22170
22944
22945
31079
23038
22869
31103
31104
31095
31047
20113
30023
30027
30019
23113
22431
22778
22777
23047
21212
21211
23035
22216
23066
30037
22861
22859
22824
22755
22757
22693
22647
21188
21186
22656
21094
22390
21040
21039
22076
22630
31082
21108
22919
22825
22054
22059
22834
31143
22764
23096
22517
22177
22685
30033
30034
20105
22998
23057
22345
22849
22427
22606
22525
22435
22729
22370
22365
22366
22246
22509
22344
22700
30073
22966
22748
20185
21061
31037
23063
23054
21095
22081
22062
23117
22352
22353
22354
21148
31114
31133
22736
22618
22828
22958
22178
22458
22457
22695
21189
21187
21167
22702
22644
21175
21140
21023
23141
22462
21001
22759
21004
21005
22136
22211
21127
23059
23079
22120
23078
22202
22184
22804
22392
22214
22235
22234
22289
31096
31142
22948
31014
22316
22651
22795
31043
31045
21123
21013
22997
22293
23123
23126
22064
22592
22271
22914
21160
22338
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Mail Code: 65-1A
Malvern PA 19355-1418
610-219-6300
For Additional Information Contact Customer Support
610-219-6300
Manufacturer Reason
for Recall
Excessive usage of cleaning liquid on Siemens Ysio Systems may cause infiltration of the generator console, which may lead to a short circuit causing an unintended release of radiation.
FDA Determined
Cause 2
Use error
Action Siemens sent an Safety Advisory Notice letter dated May 9, 2014, to affected customer. The letter identified the affected product, problem and actions to be taken. For question call +49 (913) 84-9908.
Quantity in Commerce 433
Distribution US Nationwide
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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