Acuson SC2000 volume imaging ultrasound systems at software version 3 — Class II medical device recall Z-0052-2014
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2013-10-30, distributed nationwide. Software issue results in inaccurate 3D image may result in ablation in wrong location.
| Recall number | Z-0052-2014 |
|---|---|
| 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 | 2013-07-10 |
| Classified | 2013-10-23 |
| Reported by FDA | 2013-10-30 |
| Terminated | 2013-11-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, FR, JP, PT, SA, TR, TW |
| Quantity | 26 units |
| Reason classes | software |
| Serial numbers | 400141, 400416, 400599, 400600, 400641, 400675, 400836, 400882, 401108, 401109, 401111, 401116, 401161, 401189, 401213, 401214, 401236, 401239, 401241, 401245, 401254, 401255, 401259, 401260, 401290 and 1 more |
| Model numbers | 10433816 |
Product
Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View, CA 94043 Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that provide information to the clinician for clinical diagnosis purposes.
Reason for recall
Software issue results in inaccurate 3D image may result in ablation in wrong location.
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-0052-2014. 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.