Siemens Medical Solutions USA, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1200-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 5, 2018

Date Posted: May 16, 2018

Recall Number: Z-1200-2018

Event ID: 79568

Reason for Recall:

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

Status: Terminated

Product Quantity: 229 systems

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated