Company Siemens Medical Solutions USA, Inc
Date of Enforcement Report 6/42014
Class lI:
PRODUCT
ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system. Recall Number Z-1668-2014
REASON
Potential malfunction due to a software issue for ACUSON SC2000 ultrasound systems using software version 3.5 (VA35) when using the stress echo feature which could cause the need for the study to be repeated.
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
177 units
DISTRIBUTION
Nationwide and Internationally
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