31
May
2012

Cl ll ACUSON S1000 ultrasound SW version 1.0

0

Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 5/30/12
Class ll:

PRODUCT
ACUSON S1000 ultrasound systems running software version 1.0. The product is indicated for use as an ultrasound imaging system. Recall # Z-1616-2012

REASON
When using the Advanced SieClear spatial compounding feature a synchronization error may occur which can cause a mismatch between the image and the depth scale.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by letter on April 25, 2012. Firm initiated recall is ongoing..

VOLUME OF PRODUCT IN COMMERCE
45 units

DISTRIBUTION
Nationwide and Internationally

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About the author

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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