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.