Z-1592-2016Class II

ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE)...

Name: Z-1592-2016 ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE)...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2016-04-08
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-04-08 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc. began a recall of ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model number: 10433816 on 2016-04-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1592-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-08
Posted: 2016-05-02
Terminated: 2017-01-18
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model number: 10433816.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
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.
Root cause tag: software
FDA root cause: Software design
Action: Under Siemens update program US013/16/S a Customer Advisory Notification will be mailed to all affected customers by Certified mail with return receipt beginning March 30, 2016. Letters provide customers information on how to avoid the issue until the software patch is installed.
Quantity in commerce: 87
Distribution: Worldwide distribution. US nationwide, Austria, Canada, China, Germany, India, Italy, Spain, Sweden, and Switzerland.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1592-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1592-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-11	2016-05-02

Product code IYN

K123622Class IIAcusonSiemens Medical Solutions USA, Inc. / cleared 2012-12-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)