Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report: 6/3/2015
Class lI:
PRODUCT
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.
Recall Number Z-1645-2015
REASON
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..
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 4/202015 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
75
DISTRIBUTION
Nationwide and Puerto Rico
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