Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report 12/14/2016
Class lI:
PRODUCT
SOMATOM Force, System x-ray, tomography, computed
Recall Number Z-0962-2017
REASON
Siemens is providing software update versionVA50A_SP3 to address the software bugs thatwere identified through normal field monitoringand the Global Complaint Handling Process.Correction for the problems are as follows:1. Correction to volumetricmisrepresentations of high contrastobjects when using ADMIRE.2. Correction to highly sporadic scanaborts due to temporarily tubecurrents at 0mA.3.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA on 10/20/2016 Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
48
DISTRIBUTION
Nationwide
___________________________________
