Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report 10/15/2008
Class:ll
PRODUCT
Acuson CV70 Ultrasound systems Ultrasonic Pulsed echo/doppler imaging system with Software revisions less than 4.0.0b, material number 784539, 7848521, and 7848547. Is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms, Recall # Z-2212-2008
REASON
System may either display incorrect mechanical and thermal index values, or fail to display them altogether.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Mountain View, CA, by visit beginning June 4, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1,230 units
DISTRIBUTION
Nationwide and Internationally
