FDA Device

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.

Hazard

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

What You Should Do

Remedy

The firm initiated its field correction on 08/05/2008. The firm's service personnel will make site visits to correct the problem and install the revised software (version 1.5.0c). Contact Siemens Medical Solutions USA, Inc. at 1-650-694-5993 for assistance.

Products

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.
Brand
Siemens Medical Solutions USA, Inc.
UPC
Model numbers 07482800, 07482818, 07482826, 07478139, 07478147, and 07482479

Units Affected

2541 units