Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 1/13/2016
Class lI:
PRODUCT
Software version VD10E for Syngo X-Workplace; Picture archiving and communication system. Recall Number Z-0597-2016
REASON
Potential post-processing software issue when using tabcard “4D” on X-Workplace with software version VD10E. A too small measurement in the MPRs of a volume when images are acquired with a CT scanner with a tilted gantry. In a 2×2 layout, the 4D tabcard will show an incorrect, too small length measurement. This could result in selecting a device of the wrong size, which then needs to be exchanged.an invalid combination of printer and the syngo Imaging XS printer configuration file.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 11/18/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
73 units
DISTRIBUTION
Nationwide
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