Device product
ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
Z-1200-2018
Product summary
- Event
- Event 79568
- Status
- Terminated
- Classification
- Class II
- Quantity
- 229 systems
- Official record key
device-enforcement:Z-1200-2018
Official wording
Reason: The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.
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.
Derived failure modes
-
Unknown
The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.