Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 5/11/2016
Class lI:
PRODUCT
Syngo Dynamics; Kinetdx Picture Archiving and Communications System
Recall Number Z-1601-2016
REASON
Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syngo Dynamics. If the template design has measurements inside a carry forward-configured report section, this will result in carrying forward the entire section of the report including data from previous studies. This may result in the physician making analysis based on the old measurements.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 4/14/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
84 units
DISTRIBUTION
Nationwide
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