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
