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U.S. Department of Health and Human Services

Class 2 Device Recall SIEMENS Ysio Max

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  Class 2 Device Recall SIEMENS Ysio Max see related information
Date Initiated by Firm April 13, 2015
Date Posted May 23, 2015
Recall Status1 Terminated 3 on March 20, 2017
Recall Number Z-1667-2015
Recall Event ID 71115
510(K)Number K133259  
Product Classification System, x-ray, stationary - Product Code KPR
Product SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medical practices. Ysio Max 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.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
Code Information Model Number of device  10762470, with serial numbers: 24077 24051 24038 24116 24082 24033 24136 24155 24159 24066 24106 24052 24128 24059 24048 24099 24100 24028 24046 24063 24083 24135 24131 24091 24024 24129 24103 24148 24142 24014 24015 24026 24109 24034 24108 24049 24058 24113 24154 24156 24039 24081 24114 24090 24105 24075 24016 24025 24042 24037 24053 24121 24087 
Recalling Firm/
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Customer Support
Manufacturer Reason
for Recall
Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image recovery. Pressing undo button on the RAD subtask card or previous series button on the Image subtask card during image readout. Sporadically, during an automatic or a manual RIS update.
FDA Determined
Cause 2
Software design
Action A safety advisory notice, dated April 13, 2015, was sent to end users with affected devices to alert them about the issue and associated risks,and to provide instructions for avoiding potential risk. A new software version will be released to permanently resolve the issue.
Quantity in Commerce 133 total
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.