17

Jan

2008

Siemens Medical Solutions USA Ultrasound Cl II

0

Company: Siemens Medical Solutions USA, Inc.,
Date of Enforcement Report 1/16/2008
Class:ll

PRODUCT
a) Siemens, ACUSON Antares, Ultrasound System (Standard and Premium Edition),
5.0 Systems with software version 200.0.054, P/N: 10032747 and 10032746
standard, 10032746, 10037591, and 10038202 for premium edition,
Recall # Z-0297-2008;
b) Siemens, SONOLINE Antares Ultrasound System, 5.0 Systems with software
version 200.0.054, P/N 05936518 and 10037593, Recall # Z-0298-2008

REASON
Image errors: A software problem results in on-screen indications (graphics) that lead the user to believe that the patient’s right and left and the transducer orientation are oriented the same. This is not the case and the actual patient’s right and left are reversed from the on-screen indicators.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by letter on July 10, 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
418 units

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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