May

2016

Cl II Siemens ACUSON SC2000 Ultrasound imaging

Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 5/11/2016
Class lI:

PRODUCT

ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model number: 10433816.
Recall Number Z-1592-2016

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.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Mountainview, CA on 4/8/2016. Voluntary: Firm Initiated recallis ongoing

VOLUME OF PRODUCT IN COMMERCE
87

DISTRIBUTION
Nationwide and Internationally

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II Siemens ACUSON SC2000 Ultrasound imaging

Amy Sellers

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