Jun

2014

Cl II ACUSON SC2000 with Stress Echo Feature

Company Siemens Medical Solutions USA, Inc
Date of Enforcement Report 6/42014
Class lI:

PRODUCT

ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system. Recall Number Z-1668-2014

REASON
Potential malfunction due to a software issue for ACUSON SC2000 ultrasound systems using software version 3.5 (VA35) when using the stress echo feature which could cause the need for the study to be repeated.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA on 4/23/2014. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
177 units

DISTRIBUTION
Nationwide and Internationally

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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 ACUSON SC2000 with Stress Echo Feature

Amy Sellers

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