Siemens brand ACUSON S2000 Ultrasound Systems, and the Advanced SieClearTM spatial compounding feature Software Versions
FDA device recall Z-1684-2012 · posted 2012-05-30 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- 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.
- Action taken
- 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. For questions regarding this recall call 650-694-5747.
- Root cause
- Software change control
- Status
- Terminated
- Product code
- IYO
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Argentina, Austria, Australia, Belgium, Canada, Switzerland, Chile, China, Germany, Denmark, Ecuador, Spain, France, Great Britain, Greec
- Date initiated
- 2012-04-23
- Date posted
- 2012-05-30
- Date terminated
- 2013-07-16
- Location
- Mountain View, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUSON (K111674) | Siemens Medical Solutions USA, Inc. | 2011-06-30 |