Inc. Class II Misys Healthcare Systems

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.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

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