Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions Sonovista X300 software revision 1.0.06
FDA device recall Z-0086-2009 · posted 2008-10-08 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- Incorrect value calculations by the device may result in inaccurate aortic stenosis estimates.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 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
- Date initiated
- 2008-08-19
- Date posted
- 2008-10-08
- Date terminated
- 2011-04-21
- 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 X300 DIAGNOSTIC ULTRASOUND SYSTEM (K061946) | Siemens Medical Solutions USA, Inc. | 2006-07-21 |