Company: Philips Medical Systems (Cleveland) Inc
Date of Enforcement Report: 6/04/03
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 incorrectly stored in the archive directory of a different patient.
CODE
a) Serial Numbers: 3094 through 3196;
b) Serial Numbers: 3008 through 3169.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland), Inc., Highlands Heights, OH, by a “Product Safety Notification”, dated April 2, 2003. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
187 units.
DISTRIBUTION
Nationwide, and Internationally.
