Inc Class II Misys Healthcare Systems

Company: Misys Healthcare Systems, Inc.
Date of Enforcement Report: 3/12/03
Class: II

PRODUCT
Misys Blood Bank System. Recall # B-0581-3.

REASON
Defect in the design of blood bank software programs could result in the release of unsuitable blood product.

CODE
Version 5.2, 5.23 and 5.3.

RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Inc. (formerly Sunquest Information Systems), Tucson, AZ, by a Product Safety Notification, dated April 2, 2002. Firm initiated recall ongoing.

VOLUME OF PRODUCT IN COMMERCE
3 Versions.

DISTRIBUTION
Nationwide, Canada, United Kingdom, Bermuda and Saudi Arabia.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.