29
Oct
2008

Cl Il Sonoline G50/G60 Ultrasound System

0

Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report 10/29/2008
Class:ll

PRODUCT
Sonoline G50/G60 Ultrasound System, Software versions 1.0.0 to 1.5.0b. The product is a general purpose, mobile software controlled diagnostic ultrasound system. Model numbers 07482800, 07482818, 07482826, 07478139, 07478147, and 07482479, Recall # Z-2468-2008

REASON
As a result of bugs and calculation errors, the firm may display incorrect or fail to display mechanical Index and thermal index values.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc. Mountain View, CA, by site visits beginning August 5, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2,541 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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