ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2
FDA device recall Z-2321-2015 · posted 2015-07-30 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- Potential measurement error on ACUSON S Family ultrasound system. When repositioning the Virtual Touch IQ region of interest from the original (default) location, the lateral position of the measurement tool may not align with the lateral position of the shear velocity data.
- Action taken
- On June 25, 2015 Customer Safety Advisory Notification letters were sent to all affected customers by Certified mail. The letter identified the affected product, problem and actions to be taken. The Siemens Service organization coordinates the implementation of the field correction with the distributors for all countries. For questions contact your Siemens Service for information.
- Root cause
- Software Design Change
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 629 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Dominican Rep., France, Germany, Gr
- Date initiated
- 2015-06-25
- Date posted
- 2015-07-30
- Date terminated
- 2017-10-19
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUSON S1000 / S2000 / S3000 (K132804) | Siemens Medical Solutions USA, Inc. Ultrasound Gro | 2013-10-24 |