02
Oct
2002

Inc Class II Misys Healthcare Systems

0

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

PRODUCT
Misys Laboratory. Recall # Z-1378-2.

REASON
Software anomaly. When original results were modified or deleted in function MEH, original/unmodified results were saved.

CODE
Versions 5.2, 5.23, 5.3.

RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Inc., Tucson, AZ, by fax July 5, 2002.Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
477.

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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