Z-2468-2008

Sonoline G50/G60 Ultrasound System, Software versions 1.0.0 to 1.5.0b. The product is a general purpose...

Name: Z-2468-2008 Sonoline G50/G60 Ultrasound System, Software versions 1.0.0 to 1.5.0b. The product is a general purpose...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2008-08-05
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2008-08-05 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc. began a recall of 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 on 2008-08-05. The reason FDA records is "As a result of bugs and calculation errors, the system may display incorrect or fail to display mechanical Index and thermal index values". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2468-2008
Status: Terminated
Initiated: 2008-08-05
Posted: 2008-09-29
Terminated: 2010-12-21
Recalling firm: Siemens Medical Solutions USA, Inc.
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.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: 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 tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 2541 units
Distribution: Worldwide
Product codes and lots: Model numbers 07482800, 07482818, 07482826, 07478139, 07478147, and 07482479

Product code IYN

K052894Class IISonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. / cleared 2005-11-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)