Company:Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 12/17/2014
Class lI:
PRODUCT
Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
Recall Number Z-0576-2015
REASON
Printouts may be printed in incorrect anatomical size when using syngo.plaza or syngo Imaging XS filming application in conjunction with a printer not released for anatomical print usage. This may happen due to an invalid combination of printer and the syngo.plaza printer configuration file. Printouts in anatomical size are not correct and may influence diagnostic decisions and/or therapy.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA on 1/11/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
149
DISTRIBUTION
Nationwide
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