Recall Z-0111-2009 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions 2.0.1 to 2.0.05, 3.0.01 and 3.0.02, manufactured by Siemens Ultrasound
| Date | Oct 10, 2008 (initiated Aug 19, 2008) |
| Status | Terminated |
| Reason | Thermal Index cranial (TIC) is not displayed for the Neo-Head exam type with the C8-5 transducer. This is a required display to support the alara principle when imaging cranial structure. |
| Root cause | Employee error |
| Action | Field correction was initiated on 8/19/2008. Under Siemens update program US020/08/S & US021/08/S Siemens service personnel make a site visit, deliver a customer safety advisory notice to the customer and correct the problem by installing the revised Software versions. After the planned field correction is performed at the customer site the Service personnel log that information through Siemens internal web or reporting tools into the Siemens field update database. |
| Quantity | 72 units |
| Distribution | Worldwide Distribution --- including USA and countries of France, Colombia, Poland, Taiwan, Saudi Arabia, Austria, Malaysia, India, Czech Republic, Croatia, Argentina, Venezuela, Italy, Philippines, Mauritius, Spain, Bolivia, Germany, Ukrain, Russia, United Kingdom, Brazil, South Africa and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072676 | ACUSON X300 ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc., Dec 18, 2007 |