Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 5/30/12
Class ll:
PRODUCT
ACUSON S1000 ultrasound systems running software version 1.0. The product is indicated for use as an ultrasound imaging system. Recall # Z-1616-2012
REASON
When using the Advanced SieClear spatial compounding feature a synchronization error may occur which can cause a mismatch between the image and the depth scale.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by letter on April 25, 2012. Firm initiated recall is ongoing..
VOLUME OF PRODUCT IN COMMERCE
45 units
DISTRIBUTION
Nationwide and Internationally
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