Inc Class II Misys Healthcare Systems

Company: Misys Healthcare Systems, Inc
Date of Enforcement Report: 10/9/02
Class: II

PRODUCT
Misys laboratory version 5.3 with custom Result Interface 11. Recall # Z-1405-2.

REASON
Software anomaly causing mixing of patient data.

CODE
Version 5.3 with custom Result Interface 11.

RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Inc., Tucson, AZ, by fax on June 13, 2002. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1.

DISTRIBUTION
MN.

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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