Siemens Medical Solutions USA, Inc. Acuson Antares Ultrasound System Diagnostic Ultrasound system Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Acuson Antares Ultrasound System Diagnostic Ultrasound system
Brand
Siemens Medical Solutions USA, Inc.
Lot Codes / Batch Numbers
Model Numbers begins with 1003, 1004, 059 and 086 with product version 5.0, and softeare version 200.0.079
Products Sold
Model Numbers begins with 1003, 1004, 059 and 086 with product version 5.0, and softeare version 200.0.079
Siemens Medical Solutions USA, Inc. is recalling Acuson Antares Ultrasound System Diagnostic Ultrasound system due to Software safety guard measures on the device malfunctioned to prevent the temperature from going over its limits when the device is used.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software safety guard measures on the device malfunctioned to prevent the temperature from going over its limits when the device is used.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026