—#73228

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.

FDA product code: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K052894
Affected lot / code info: Model numbers 07482800, 07482818, 07482826, 07478139, 07478147, and 07482479

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 1230 Shorebire Way P.O. Box 7393, Mountain View, California 94043

Distribution

Distribution pattern: Worldwide

Timeline

Recall initiated: 2008-08-05
Posted by FDA: 2008-09-29
Terminated: 2010-12-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73228. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.