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U.S. Department of Health and Human Services

Class 2 Device Recall ACUSON SC2000 Ultrasound System

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 Class 2 Device Recall ACUSON SC2000 Ultrasound Systemsee related information
Date Initiated by FirmMarch 05, 2018
Date PostedMarch 26, 2018
Recall Status1 Terminated 3 on February 26, 2021
Recall NumberZ-1200-2018
Recall Event ID 79568
510(K)NumberK170315 
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
ProductACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
Code Information Software versions VB20A, VB20B, or VB20C that have a common physio module (CPM) (known by customers as the ECG (physio) hardware) installed at revision 4
FEI Number 2936884
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
685 E Middlefield Rd
Mountain View CA 94043-4045
For Additional Information ContactMr. Mazi Kiani
650-694-5398
Manufacturer Reason
for Recall		The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.
FDA Determined
Cause 2		Device Design
ActionUndated recall letters were issued via email (if they had an email address for the customer) or via certified mail (if no email address was available) on 3/5/2018.
Quantity in Commerce229 systems
DistributionDistribution was made to medical facilities in AZ, CA, CT, FL, IL, IN, KS, KY, MI, MN, MO, NJ, NY, NC, OH, PA, TX, VA, and WA. There was no military/government distribution. Foreign distribution was made to Argentina, Australia, Austria, Belgium, Bosnia Herzeg, Colombia, Croatia, Denmark, France, Germany, India, Ireland, Israel, Italy, Japan, Mexico, New Zealand, Philippines, Poland, Republic Korea, Romania, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Turkey, UAE, and Vietnam.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IYN
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