Z-1200-2018Class II

ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo...

Name: Z-1200-2018 ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2018-03-05
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2018-03-05 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc. began a recall of ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL on 2018-03-05. FDA classified it as Class II and gives the reason as "The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1200-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-05
Posted: 2018-03-26
Terminated: 2021-02-26
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.
Root cause tag: design
FDA root cause: Device Design
Action: Undated 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 commerce: 229 systems
Distribution: Distribution 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1200-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1200-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-07

Product code IYN

K170315Class IIAcuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. / cleared 2017-04-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)