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.
