21
Jul
2004

Siemens Medical Solutions USA Class II

0

Company: Siemens Medical Solutions USA
Date of Enforcement Report: 7/21/04
Class: II

PRODUCT
Image Navigator feature in the MagicView 300 VA42A or VA42B Software. Siemens Part Number: 7502003 and 8463163. Recall # Z-1095-04.

REASON
The Image Navigator feature in the MagicView 300 VA42A or VA42B software may not be imported accurately to certain CT or MR images.

CODE
All software associated with Image Navigator feature in Magic View.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA, by letters on April 1, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
70 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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