Siemens ACUSON X700 Ultrasound Systems with software version 1 — Class II medical device recall Z-1504-2014
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2014-04-30, distributed nationwide. When fourSight 4D ultrasound imaging, 3-Scrape real time 3D imaging, or Anatomical M-mode are used during an O
| Recall number | Z-1504-2014 |
|---|---|
| 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 | 2014-04-02 |
| Classified | 2014-04-24 |
| Reported by FDA | 2014-04-30 |
| Terminated | 2015-11-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, CH, CL, CO, DE, EC, EG, ES, FR, GB, GR, HR, HU, ID, IE, IL, IN, IT, JP, KE, KR, KW, LV, MY, NG, NO, NP, PH, PL, PT, QA, RO, SA, SK, TR, TW, ZA |
| Quantity | 490 |
| Model numbers | 1065844 |
Product
Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, 1.0.02, 1.1.00 and 1.1.02. ultrasound imaging system.
Reason for recall
When fourSight 4D ultrasound imaging, 3-Scrape real time 3D imaging, or Anatomical M-mode are used during an Obstetric or Gynecology study, data from the previous patient could replace the current patient's date in the report.
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-1504-2014. 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.