Company: Misys Healthcare Systems
Date of Enforcement Report: 12/10/03
Class: I

PRODUCT
Calculator/Data Processing Module for Clinical Use. Recall
# Z-0007-04.

REASON
Software defect. Clinical Laboratory results failing quality assurance were filed directly to a patient’s chart without review.

CODE
Versions 5.2, 5.23, and 5.3.

RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by facsimile on August 12, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
479.

DISTRIBUTION
Nationwide and Internationally.