—#136152

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.

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K133259
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2015-04-13
Posted by FDA: 2015-05-23
Terminated: 2017-03-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #136152. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.