Recall Z-1200-2018 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
| Date | Mar 26, 2018 (initiated Mar 5, 2018) |
| Status | Terminated |
| Reason | The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment. |
| 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 | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170315 | Acuson SC2000 Diagnostic Ultrasound System Siemens Medi Cal Solutions, Inc., Apr 4, 2017 |