Recall Z-1504-2014 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, 1.0.02, 1.1.00 and 1.1.02. ultrasound imaging system.
| Date | Apr 24, 2014 (initiated Apr 2, 2014) |
| Status | Terminated |
| Reason | When fourSight 4D ultrasound imaging, 3-Scrape real time 3D imaging, or Anatomical M-mode are used during an Obstetric or Gynecology study, data from the previous patient could replace the current patient's date in the report. |
| Root cause | Software Design Change |
| Action | Siemens sent a Customer Safety Advisory Notification letter on April 2, 2014 to all affected customers via certified mail. The letter identified the affected product, problem and what actions to take until software is upgraded. For questions call 1-888-826-9702. |
| Quantity | 490 |
| Distribution | Worldwide Distribution - US Nationwide and the countries of Angola, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg., Brunei, Chile, Colombia, Croatia, Ecuador, Egypt, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kenya, Kuwait, Latvia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123001 | ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc., Oct 26, 2012 |