Company: Siemens Medical Solutions USA, Inc..
Date of Enforcement Report: 9/22/04
Class: II

PRODUCT
Axiom Sensis Report Workstation. Recall # Z-1446-04.

REASON
Software issue. Allows for users to enter date in Pre-Cath Holding Area prior to registering the patient in the Cath Lab.

CODE
Serial Numbers 1002, 1034, 1100-1253, 1300-1504.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA, by a Customer Safety Advisory on May 17, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
234 units.

DISTRIBUTION
Nationwide.