15
Oct
2008

Cl Il Acuson CV70 Ultrasound systems

0

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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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