Recall Z-1667-2014 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system.
| Date | May 28, 2014 (initiated Apr 23, 2014) |
| Status | Terminated |
| Reason | Software issues with ACUSON SC2000 ultrasound with software version 3/5 (VA35) - may incorrectly display the color flow data in the wrong position and when Doppler Frequency is adjusted, the system does not restart the pulsed wave Doppler or continuous wave Doppler waveform. |
| Root cause | Software design |
| Action | Siemens sent an Customer Safety Advisory Notification letter on April 23, 2014, to all affected customers. Distributors in foreign countries will implement delivery of notification to their customers. " Use the factory default presets with software version 3.5 instead of user-defined presets restored from software version 2.0 or 3.0. Review all patient studies on exams performed after software revision 3.5 was installed on your system. If you are unsure when this software was installed on your system, please contact your local Customer Service representative. " After adjusting the Doppler f |
| Quantity | 257 units |
| Distribution | Worldwide Distribution - USA including the states of AL, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, KS, LS, MD, MI, MN, MO, NH, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA and WI., and the countries of Australia, Austria, Dominican Rep, France, Germany, Iceland, India, Indonesia, Ireland, Israel, I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123622 | ACUSON Siemens Medical Solutions USA, Inc., Dec 5, 2012 |