Recall Z-0086-2009 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
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.
| Date | Oct 8, 2008 (initiated Aug 19, 2008) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061946 | ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc., Jul 21, 2006 |