Recall Z-1962-2014 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
| Date | Jul 1, 2014 (initiated Jun 3, 2014) |
| Status | Terminated |
| Reason | There is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on the ACUSON S Family ultrasound system. |
| Root cause | Software design |
| Action | Siemens sent a Customer Safety Advisory Notification letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: To avoid the potential risk of this issue, do not use the Auto-Stats tool; use alternate measurement tools. Only use the Velocity tool on frozen images. Customer Service Engineer will contact the customer to schedule an appointment to replace their existing version of software, free of charge. Customers with questions should contact their local service support person f |
| Quantity | 790 units |
| Distribution | Worldwide Distribution - USA including CA, MO, VA, PA, WV, and Internationally to Angola, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, France, Germany, Greece, India, Iraq, Israel, Italy, Japan, Ka |
| 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 |