23
Jul
2003

USA Inc. Class II Siemens Medical Solutions

0

Company: Siemans Medical Solutions USA, Inc
Date of Enforcement Report: 7/23/03
Class: II

PRODUCT
Axiom Aristos X-Ray System. Recall # Z-0984-03.

REASON
Software malfunction. May indicate that the image is flipped when it is not.

CODE
Part numbers 5895003 and 7414803. Serial numbers 01001, 01170, 01219, 01221, and 01030.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA, by letters dated April 19, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
5 units.

DISTRIBUTION
FL, MO, OK, and CO.

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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