18

Sep

2008

Inc, Cl Ill Siemens Medical Solutions USA

0

Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report 9/17/2008
Class:lll

PRODUCT
a) ACUSON Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A,
with one of the following options installed: 3-Scape Imaging, Factory, PN 5937011
or 3-Scape Real Time Imaging, UPG ACU, PN 10033688. Material number
10032746, 10037592, 10032746, 10037591 or 10038202; Recall # Z-1766-2008;
b) Sonoline Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A,
with one of the following options installed: 3-Scape Imaging, Factory, PN 5937011
or 3-Scape Imaging, Field Upgrade, PN 07472520. Material number 5936518,
8653771 or 10037593; Recall # Z-1767-2008

REASON
Software issues may result in distorted images and inaccurate measurements, which could lead to a misdiagnosis.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by site visits on March 21, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
539 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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