29
Jan
2003

Inc. Class II Misys Healthcare Systems

0

Company: Misys Healthcare Systems, Inc.
Date of Enforcement Report: 1/29/03
Class: II

PRODUCT
Misys Blood Bank System. Recall # B-0455-3.

CODE
Version 5.2, 5.23, and 5.3.

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

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

VOLUME OF PRODUCT IN COMMERCE
3 versions.

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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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