Z-0111-2009

Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions 2.0.1 to 2.0.05, 3.0.01 and...

Name: Z-0111-2009 Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions 2.0.1 to 2.0.05, 3.0.01 and...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2008-08-19
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2008-08-19 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc. began a recall of Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions 2.0.1 to 2.0.05, 3.0.01 and 3.0.02, manufactured by Siemens Ultrasound on 2008-08-19. The reason FDA records is "Thermal Index cranial (TIC) is not displayed for the Neo-Head exam type with the C8-5 transducer. This is a required display to support the alara principle when imaging cranial structure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0111-2009
Status: Terminated
Initiated: 2008-08-19
Posted: 2008-10-10
Terminated: 2010-12-20
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions 2.0.1 to 2.0.05, 3.0.01 and 3.0.02, manufactured by Siemens Ultrasound
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: Thermal Index cranial (TIC) is not displayed for the Neo-Head exam type with the C8-5 transducer. This is a required display to support the alara principle when imaging cranial structure.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Field correction was initiated on 8/19/2008. Under Siemens update program US020/08/S & US021/08/S Siemens service personnel make a site visit, deliver a customer safety advisory notice to the customer and correct the problem by installing the revised Software versions. After the planned field correction is performed at the customer site the Service personnel log that information through Siemens internal web or reporting tools into the Siemens field update database.
Quantity in commerce: 72 units
Distribution: Worldwide Distribution --- including USA and countries of France, Colombia, Poland, Taiwan, Saudi Arabia, Austria, Malaysia, India, Czech Republic, Croatia, Argentina, Venezuela, Italy, Philippines, Mauritius, Spain, Bolivia, Germany, Ukrain, Russia, United Kingdom, Brazil, South Africa and Canada.
Product codes and lots: Sonovista: 10133170, Acuson: 10037409 (potentially affected but no volume: 10132987, 10038837). Software revisions 2.0.1 to 2.0.05, 3.0.01 and 3.0.02

Product code IYN

K072676Class IIAcuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc. / cleared 2007-12-18

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)