FDA Device recall Z-1200-2018
ACUSON SC2000 Ultrasound System
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of ACUSON SC2000 Ultrasound System by Siemens Medical Solutions Usa, citing the ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1200-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-05 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | AZ, CA, CT, FL, IL, IN, KS, KY, MI, MN, MO, NC, NJ, NY, OH, PA, TX, VA, WA |
Product
ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
Reason
The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.
Identifiers
| code_info | 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1200-2018%22
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