SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
FDA Recall Z-1645-2015 · Posted 2015-05-22
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2015-04-20
Date Terminated2016-09-01
Product Quantity75
Reason for Recall
Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow keys of the keyboard. Tomo images may freeze on the screen when zoomed in or out under the mode of CAREVision. Sporadic displaying error in WorkStream4D application. DB may lock under heavy and multitasks.
Firm Action
Siemens sent an Customer Safety Advisory Notice dated April 20, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
A remote software update is scheduled for release that will resolve the issue. For further questions, please call (610) 219-6300.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution including Puerto Rico.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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