Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 3/20/2013
Class ll:
PRODUCT
Siemens Somatom CT’s equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.
Recall Number Z-0948-2013
REASON
Sporadic hang-up malfunctions concerning 3D reconstructions during activated “Preview Image” functionality
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 11/27/12. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
5
DISTRIBUTION
Nationwide
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