Recall Z-2321-2015 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, V
| Date | Jul 30, 2015 (initiated Jun 25, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software Design Change |
| Action | 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. |
| Quantity | 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, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kenya, Malaysia, Mexico, Nepal, Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132804 | ACUSON S1000 / S2000 / S3000 Siemens Medical Solutions USA, Inc. Ultrasound Gro, Oct 24, 2013 |