Company: Philips Medical Systems (Cleveland) Inc
Date of Enforcement Report: 5/28/03
Class: III

PRODUCT
a) Philips MX8000 IDT CT Scanner, utilizing V2.1 software.
Recall # Z-0835-03.
b) Philips MX8000 Dual v. EXP CT Scanner, utilizing V2.0 software.
Recall # Z-0836-03.

REASON
Patient images may be stored in the archive directory of a different patient.

CODE
a) Serial Numbers: 3094 through 3196;
b) Serial Numbers: 8008 through 8069.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc, Highland Heights, OH, by a “Product Safety Notification”, dated April 2, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
a) 137 units;
b) 50 units.
DISTRIBUTION

Nationwide and Internationally