Company Siemens Medical Solutions USA, Inc
Date of Enforcement Report 6/4/2014
Class lI:
PRODUCT
ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system. Recall Number Z-1667-2014
REASON
Software issues with ACUSON SC2000 ultrasound with software version 3/5 (VA35) – may incorrectly display the color flow data in the wrong position and when Doppler Frequency is adjusted, the system does not restart the pulsed wave Doppler or continuous wave Doppler waveform.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA on 4/23/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
257 units
DISTRIBUTION
Nationwide and Internationally
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