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.
FDA Recall Z-0052-2014 · Posted 2013-10-23
Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2013-07-10
Date Terminated2013-11-25
Product Quantity26 units
Reason for Recall
Software issue results in inaccurate 3D image may result in ablation in wrong location.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.