Recall Z-1959-2015 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model number 10433816: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Con
| Date | Jul 2, 2015 (initiated May 29, 2015) |
| Status | Terminated |
| Reason | When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of data, where some selected clips may not be saved as part of the study. |
| Root cause | Software design |
| Action | Siemens sent an Customer Safety Advisory Notification on May 29,2015, to all affected customers. The letter identified the product the problems and the action needed to be taken by the customer. Customer Safety Advisory notifications inform users of the potential issue with the ACUSON SC2000 systems with software versions between VA16! and VA30A and the Stress Echo feature. Letters describe the steps that result in the potential loss of data and suggest that the following steps be taken to remedy the situation: 1. Select Stress Echo Selection 2. If applicable relabel the clips for all Stages |
| Quantity | 573 devices |
| Distribution | Worldwide Distribution - US Distribution and to the countries of : Albania, Angola, Armenia, Australia, Austria, Bangladesh, Belarus, Bolivia, Bosnia Herzog, Brazil, Brunei, Bulgaria, Canada, Colombia, Czech Republic, Ecuador, Egypt, Finland, France, Germany, Hungary, Iceland, India, Ireland, Israe |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.