Acuson Antares Ultrasound Imaging System with software versions 4.0 and 5.0.
FDA device recall Z-1853-2011 · posted 2011-03-30 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- Image captured from the device may be erroneous.
- Action taken
- Acuson Customer Safety Advisory notification letters were sent March 1, 2010 by certified mail.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 3539
- Distribution
- Worldwide distribution to USA, Andorra, United Arab Emirates, Netherlands Antilles, Angola, Austria, Australia, Azerbaijan, Bosnia, Bangladesh, Belgium, Bahrain, Brunei Darussalam, Brazil, Belarus, Ca
- Date initiated
- 2010-03-01
- Date posted
- 2011-03-30
- Date terminated
- 2012-06-18
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM (K063803) | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007-01-05 |
| SONOLINE ANTARES DIAGNOSTIC ULTRASOUND SYSTEM (K050034) | Siemens Medical Solutions USA, Inc. | 2005-01-13 |
| SONOLINE ANTARES WITH CLARIFY VE (K033196) | Siemens Medical Solutions USA, Inc. | 2003-10-16 |
| SONOLINE ANTARES ULTRASOUND SYSTEM (K023720) | Siemens Medical Solutions USA, Inc. | 2002-11-20 |