Recall Z-1853-2011 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
Acuson Antares Ultrasound Imaging System with software versions 4.0 and 5.0.
| Date | Mar 30, 2011 (initiated Mar 1, 2010) |
| Status | Terminated |
| Reason | Image captured from the device may be erroneous. |
| Root cause | Software design |
| Action | Acuson Customer Safety Advisory notification letters were sent March 1, 2010 by certified mail. |
| Quantity | 3539 |
| Distribution | Worldwide distribution to USA, Andorra, United Arab Emirates, Netherlands Antilles, Angola, Austria, Australia, Azerbaijan, Bosnia, Bangladesh, Belgium, Bahrain, Brunei Darussalam, Brazil, Belarus, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Germany, Denmark, Ecu |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023720 | SONOLINE ANTARES ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc., Nov 20, 2002 |
| K033196 | SONOLINE ANTARES WITH CLARIFY VE Siemens Medical Solutions USA, Inc., Oct 16, 2003 |
| K050034 | SONOLINE ANTARES DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc., Jan 13, 2005 |
| K063803 | ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc., Ultrasound DI, Jan 5, 2007 |