Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report 9/28/2016
Class lI:
PRODUCT
Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images
Recall Number Z-2852-2016
REASON
Software error. Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver were too high.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA on 9/21/2016 Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
338 systems
DISTRIBUTION
Nationwide
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