Company:Siemens Medical Solutions USA, Inc..
Date of Enforcement Report: 10/30/2013
Class ll:
PRODUCT
Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View, CA 94043 Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that provide information to the clinician for clinical diagnosis purposes.
Recall Number Z-0052-2014
REASON
Software issue results in inaccurate 3D image may result in ablation in wrong location.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View CA on 7/10/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
26 units
DISTRIBUTION
Nationwide and Internationally
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