Misys Healthcare Systems Class II

Company: Misys Healthcare Systems
Date of Enforcement Report: 3/26/03
Class: II

PRODUCT
Misys Laboratory System. Recall # Z-0614-03.

CODE
Versions 5.2, 5.23 and 5.3.

REASON
Software anomaly. Rejecting the selected Autofiling status may result in the change being accepted rather than rejected.

RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by fax on January 31, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
542.

DISTRIBUTION
Nationwide and Internationally.

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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Corporate Office

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