Company: Misys Healthcare Systems
Date of Enforcement Report: 12/10/03
Class: II
PRODUCT
Misys Laboratory System. Recall # Z-0151-04.
REASON
Software defect causes orders to be lost under certain conditions of use. A typographical error at the Accept/Modfy/Reject prompt will cause the order not to be processed by the system.
CODE
Versions 5.2, 5.23, 5.3 up to 5.3.2.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by fax on July 7, 2003. FDA initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
473.
DISTRIBUTION
Nationwide and Internationally.
