Recall Z-1684-2012 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Siemens Medical Solutions USA, Inc.
Siemens brand ACUSON S2000 Ultrasound Systems, and the Advanced SieClearTM spatial compounding feature Software Versions 3.0, 3.0A and 3.1. (VB20, VB20A, and VB21A); Model #: 10041461 - ACUSON S2000 Mainframe; Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Mountain View, CA The ACUSON S2000 Ultrasound System is a multi-purpose mobile, software controlled diagnosti
| Date | May 30, 2012 (initiated Apr 23, 2012) |
| Status | Terminated |
| Reason | When using the Advanced SieClear spatial compounding feature a synchronization error may occur which can cause a mismatch between the image and the depth scale. |
| Root cause | Software change control |
| Action | Siemens initiated a Customer Safety Advisory Notification letter Field correction on April 23, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers' local Customer Service Engineer will install an update to their system as soon as it becomes available. For questions customers were instructed to contact their local service support person. Customers were also asked to pass the notification leter to all those within their organization who need to be aware of the issue until the corrective action is completed. F |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Argentina, Austria, Australia, Belgium, Canada, Switzerland, Chile, China, Germany, Denmark, Ecuador, Spain, France, Great Britain, Greece, Hong Kong, Hungary, Indonesia, Israel, India, Italy, Jordan, Japan, South Korea, Kuwait, Lebanon, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111674 | ACUSON Siemens Medical Solutions USA, Inc., Jun 30, 2011 |