FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc.: Acuson Antares Ultrasound System Diagnostic Ultrasound system
- Recall number
- Z-0896-2011
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Product
- Acuson Antares Ultrasound System Diagnostic Ultrasound system
- Status
- Terminated
- Initiated
- 2009-09-30
- Posted
- 2011-01-12
- Terminated
- 2012-06-18
- Reason
- Software safety guard measures on the device malfunctioned to prevent the temperature from going over its limits when the device is used.
- 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
- 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.
- Lot, serial or model codes
- Model Numbers begins with 1003, 1004, 059 and 086 with product version 5.0, and softeare version 200.0.079
- 510(k) numbers
- ["K052021"]
- PMA numbers
- not on file
- Product code
- ITX
- Firm FEI
- 2936884
- Firm city
- Mountain View
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28