Z-0896-2011

Acuson Antares Ultrasound System Diagnostic Ultrasound system

Name: Z-0896-2011 Acuson Antares Ultrasound System Diagnostic Ultrasound system
Creator: Siemens Medical Solutions USA, Inc.
Published: 2009-09-30
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2009-09-30 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc. began a recall of Acuson Antares Ultrasound System Diagnostic Ultrasound system on 2009-09-30. The reason FDA records is "Software safety guard measures on the device malfunctioned to prevent the temperature from going over its limits when the device is used". 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-0896-2011
Status: Terminated
Initiated: 2009-09-30
Posted: 2011-01-12
Terminated: 2012-06-18
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Acuson Antares Ultrasound System Diagnostic Ultrasound system
Product code: ITX Transducer, Ultrasonic, Diagnostic
Reason for recall: Software safety guard measures on the device malfunctioned to prevent the temperature from going over its limits when the device is used.
Root cause tag: software
FDA root cause: Software design
Action: Field notification in the form of a Customer Safety Advisory Notice was initiated on 09/30/2009 by the firm, and the notice was mailed to all affected customers Siemens sent a CUSTOMER SAFETY ADVISORY NOTIFICATION letter on September 30, 2009. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to disconnect and reconnect the V5Ms transducer between uses until their local Customer Service Engineer installs the software update to their system. For any questions customers were to contact their local service support person. For questions regarding this recall call 650-694-5398.
Quantity in commerce: 452
Distribution: Worldwide Distribution - United States (nationwide) and the countries of Australia, Austria, Azerbaijan, Brazil, Belarus, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Guatemala, Croatia, India, Indonesia, Italy, Jordan, Japan, Latvia, Malaysia, Mexico, Moldova, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.
Product codes and lots: Model Numbers begins with 1003, 1004, 059 and 086 with product version 5.0, and softeare version 200.0.079

Product code ITX

K052021Class IIV5ms Transducer and Mpt7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc. / cleared 2005-08-17

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)