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U.S. Department of Health and Human Services

Class 2 Device Recall Acuson SC2000

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  Class 2 Device Recall Acuson SC2000 see related information
Date Initiated by Firm July 10, 2013
Date Posted October 23, 2013
Recall Status1 Terminated 3 on November 25, 2013
Recall Number Z-0052-2014
Recall Event ID 65812
510(K)Number K123622  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product 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.
Code Information Model# 10433816 Software Version 3.0 Serial#'s: 401239 401189 401214 400416 400599 400600 401254 401260 401259 401161 400836 401111 401290 400641 401116 401236 401245 401241 401255 401361 400141 401108 401109 401213 400675 400882
Recalling Firm/
Siemens Medical Solutions USA, Inc.
685 E Middlefield Rd
Mountain View CA 94043-4045
For Additional Information Contact Sheila Pickering
Manufacturer Reason
for Recall
Software issue results in inaccurate 3D image may result in ablation in wrong location.
FDA Determined
Cause 2
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 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 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA INC.