||October 23, 2013
||Terminated on November 25, 2013
|Recall Event ID
System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
||Acuson SC2000 volume imaging ultrasound systems at software version 3.0.
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.
Software Version 3.0
|Siemens Medical Solutions USA, Inc.
685 E Middlefield Rd
Mountain View, California 94043-4045
|For Additional Information Contact
|Software issue results in inaccurate 3D image may result in ablation in wrong location.
|DESIGN: Device Design
||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 procedures using the ACUSON SC2000 system with BioSense Webster CARTO 3 equipped with CARTOSOUND Module and SoundSTAR Catheter should not be performed until the users system has been updated with the software upgrade that resolves the issue.
For further questions please call (650) 694-5398.
|Quantity in Commerce
||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.
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = IYN and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA INC.