Home / Recalls / Siemens Medical Solutions USA, Inc. / Z-1200-2018

Z-1200-2018 Class II Terminated

Recalled by Siemens Medical Solutions USA, Inc. — Mountain View, CA

FDA device recall Z-1200-2018 was initiated by Siemens Medical Solutions USA, Inc. on Mar 5, 2018 and is designated Class II. Reason for recall: The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment. The recall status is terminated (terminated Feb 26, 2021). Affected quantity: 229 systems.

Recall Details

Product Type: Devices
Report Date: May 16, 2018
Initiation Date: Mar 5, 2018
Termination Date: Feb 26, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 229 systems

Product Description

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

Reason for Recall

The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.

Distribution Pattern

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.

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1200-2018
openFDA file date: Oct 26, 2026
Loaded by RegDataLab: Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.