Z-1200-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- March 5, 2018
- Termination Date
- February 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