FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc.: Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions Sonovista X300 software revision 1.0.06 and 1.0.07, Acuson X300 sofware revision 1.0.08 ultrasound system with onscreen display.
- Recall number
- Z-0086-2009
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Product
- Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions Sonovista X300 software revision 1.0.06 and 1.0.07, Acuson X300 sofware revision 1.0.08 ultrasound system with onscreen display.
- Status
- Terminated
- Initiated
- 2008-08-19
- Posted
- 2008-10-08
- Terminated
- 2011-04-21
- Reason
- Incorrect value calculations by the device may result in inaccurate aortic stenosis estimates.
- Root cause
- Software design
- Action
- Siemens initiated a Field Correction 08/19/2008. Service personnel will conduct a site visit and distribute a Customer Safety Advisory Notice, correct the problem and install a revised software version.
- Quantity
- 169 units total
- Distribution
- Worldwide Distribution: USA, Singapore, Germany, Denmark, Romania, Sweden, Poland, Portugal, Australia, Chile, India, Spain, Thailand, Malaysia, South Africa, Hungary, Saudi Arabia, Qatar, Peru, Italy, Azerbaijan, Greenland, Austria, Venezuela, Puerto Rico, Brazil and Japan.
- Lot, serial or model codes
- Sonovista: 10133170 (Japan only) Acuson: 10037409 (potentially affected but no volume: 10132987, 10038837). Software revisions 1.0.06 and 1.0.07 for Sonovista X300 and 1.0.08 for Acuson X300
- 510(k) numbers
- ["K061946"]
- PMA numbers
- not on file
- Product code
- IYN
- 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