Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 5/28/03
Class: II

PRODUCT
a) Leonardo MM-WS systems. System, Image Processing.
Recall # Z-0841-03;
b) Smatom Sensation 16, Computed Tomography System, Diagnostic
Imaging. Recall # Z-0842-03.

REASON
Perfusion CT is displaying a higher gray and color values than normal. A software problem.

CODE
a) Model Number 7129534;
b) Model Number 7393114.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA. Update instructions on the new software were sent on August 2, 2002 by mail. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
3.

DISTRIBUTION
OH, MA, and MO.