Recall Z-1907-2011 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
8V3c transducer used with the ACUSON SC2000 ultrasound system. 8V3c transducer model number 10433823; ACUSON SC2000 model number 10433816. Siemens Medical Solutions USA, Inc. Business Unit Ultrasound 1230 Shorebird Way, Mountain View, CA 94043 High-density array transducer for pediatric and fetal echocardiography applications.
| Date | Apr 8, 2011 (initiated Feb 4, 2011) |
| Status | Terminated |
| Reason | When using the 8V3c transducer in color mode, the derated Ispta 3 (Spatial Peak-Temporal Average Intensity) may exceed the limit stated in the instructions for use. |
| Root cause | Software design |
| Action | A Customer Safety Advisory Notification was initiated on 2/4/2011 and sent via certified mail. The letter identified the affected product and described when the problem occurs along with the associated potential risk. The firm recommends that users not use the 8V3c until the software issue is fixed. The firm is working to release a software update and customers' local Customer Service Engineer will install new software on their system when it is available. Customers should direct their questions to their local service support person. The information in the letter should be shared with all |
| Quantity | 386 units |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102017 | SC2000 DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc., Sep 20, 2010 |