Recall Z-0052-2014 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View, CA 94043 Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that provide information to the clinician for clinical diagnosis purposes.
| Date | Oct 23, 2013 (initiated Jul 10, 2013) |
| Status | Terminated |
| Reason | Software issue results in inaccurate 3D image may result in ablation in wrong location. |
| Root cause | Device Design |
| Action | Siemens sent an Customer Safety Advisory Notification letter to all affected customers on July 10, 2013.The letter identified the product the problem and the action needed to be taken by the customer Letters provide steps to mitigate the risk and inform users that a software fix will be installed as soon as it is available. Siemens Service Engineers will contact all locations to arrange installation once fix is available. All personnel who use the ACUSON should be notified of the issue. Update September 17, 2013 : After discussion with CDRH, Siemens revised their letter to state that proce |
| Quantity | 26 units |
| Distribution | Worldwide Distribution - US (nationwide) including the states of IL, PA, AZ, OR, OH, NY, CO, TX and CA., and the countries of France, Germany, Japan, Portugal, Saudi Arabia, Taiwan and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123622 | ACUSON Siemens Medical Solutions USA, Inc., Dec 5, 2012 |