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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens

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 Class 2 Recall
Siemens
see related information
Date Posted June 04, 2014
Recall Status1 Open
Recall Number Z-1717-2014
Recall Event ID 68312
Premarket Notification
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
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
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
TRAINING: 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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