Recall Z-1572-2016 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 10658844 ACUSON X700 Ultrasound System 10658846 - ACUSON X700 Ultrasound System (Russia) 10658845 - ACUSON X700 Ultrasound System (Korea) Radiology: The Siemens ACUSON X700 ultrasound imaging system is intended for the following applications: Cardiac (Adult, Pediatric), Transesphageal (Cardiac), Intracardiac, Cerebrovascu
| Date | Sep 5, 2015 |
| Status | Terminated |
| Reason | Due to a communication error between the software and V5Ms transducers rotation function, ACUSON X700 ultrasound systems at software versions 1.1.04, display an IMG_15 error message causes the system to lock up, which requires a reboot to recover system operation. |
| Root cause | Software design |
| Action | September 5, 2015 we initiated a correction via update program US020/15/S where we visited all four units and updated their software to version 1.0.05 |
| Quantity | 4 |
| Distribution | Distributed in Germany, U.A.E., Hungary and Brazil. |
| 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 |