11
May
2005

Inc. Class II Siemens Medical Solutions USA

0

Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report: 5/11/05
Class: II

PRODUCT
Axiom Artis X-Ray System using software version VB11D or VB20B. Recall # Z-0796-05.

CODE
Model numbers 5904433, 5904441, 5904466, 7007755, 7008605, 7412807, 7413078, 7555365, 7555373, 7727717, and 7728350.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated March 24, 2005.
Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.

REASON
Live display in exam room may sporadically stop working although the display in the control room remains fully operational.

VOLUME OF PRODUCT IN COMMERCE
295 units.

DISTRIBUTION
Nationwide.

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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Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

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3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

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See our post titled: 1st Quarter 2025 Agile Compliant Courses Scheduled

 

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Instructor: Dr Peter Rech, 2nd instructor (optional)

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