ACUSON SC2000 Ultrasound imaging system with software version VB10C… — Class II medical device recall Z-1592-2016
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2016-05-11, distributed nationwide. While imaging with a transesophageal (TEE) transducer (Z6Ms, V5Ms, or V7M), user may lose the ability to contr
| Recall number | Z-1592-2016 |
|---|---|
| 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 | 2016-04-08 |
| Classified | 2016-05-02 |
| Reported by FDA | 2016-05-11 |
| Terminated | 2017-01-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CA, CH, CN, DE, ES, IN, IT, SE |
| Quantity | 87 |
| Serial numbers | 400221, 400234, 400312, 400456, 400462, 400519, 400649, 400671, 400775, 400852, 400887, 400889, 401002, 401010, 401040, 401117, 401130, 401182, 401252, 401305, 401445, 401631, 401751, 402192, 402206 and 32 more |
| Model numbers | 10433816 |
Product
ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model number: 10433816.
Reason for recall
While imaging with a transesophageal (TEE) transducer (Z6Ms, V5Ms, or V7M), user may lose the ability to control the color region of interest, the pulsed wave or continuous wave Doppler gate or cursor, the M-mode cursor, the 2D field of view, or the RES region of interest with the trackball.
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-1592-2016. 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.