FDA Device recall Z-1592-2016
ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model num…
- FDA Device
- Class II
- terminated
- Published 2016-05-11
On 2016-05-11 the FDA classified a Class II recall of ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model num… by Siemens Medical Solutions Usa, citing 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 D….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1592-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-08 |
| Published | 2016-05-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model number: 10433816.
Reason
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.
Identifiers
| code_info | Model number 10433816; Serial numbers: 402192 400889 402498 402549 400887 402791 401002 402278 402289 402301…Model number 10433816; Serial numbers: 402192 400889 402498 402549 400887 402791 401002 402278 402289 402301 401182 402879 400462 400649 402206 402211 402496 402499 401631 402475 400456 402392 402828 402814 400852 401010 402509 400221 400312 402413 402568 402460 402652 402673 402664 400234 402789 401751 401040 400519 402800 400775 400671 401445 402546 402542 402771 402764 401117 401252 402454 402476 402500 402513 402511 401305 401130. |
|---|
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-1592-2016%22
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