ACUSON SC2000 Ultrasound System — Class II medical device recall Z-1200-2018
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2018-05-16, distributed in AZ, CA, CT, FL, IL, IN, KS, KY…. The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.
| Recall number | Z-1200-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc., Mountain View, CA, United States |
| Recall initiated | 2018-03-05 |
| Classified | 2018-05-07 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2021-02-26 |
| Distributed | AZ, CA, CT, FL, IL, IN, KS, KY, MI, MN, MO, NC, NJ, NY, OH, PA, TX, VA, WA |
| Countries outside the US | AE, AR, AT, AU, BE, CO, DE, DK, ES, FR, HR, IE, IL, IN, IT, JP, KR, MX, NZ, PH, PL, RO, SE, SG, SK, TH, TR, TW, VN |
| Quantity | 229 systems |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1200-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.