—#145184

Product

ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model number: 10433816.

FDA product code: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K123622
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 685 E Middlefield Rd, Mountain View, California 94043-4045

Distribution

Distribution pattern: Worldwide distribution. US nationwide, Austria, Canada, China, Germany, India, Italy, Spain, Sweden, and Switzerland.

Timeline

Recall initiated: 2016-04-08
Terminated: 2017-01-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #145184. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.