Inc. Class II Mysis Healthcare Systems

Company: Mysis Healthcare Systems, Inc
Date of Enforcement Report: 9/18/02
Class: II

PRODUCT
Misys Commercial Laboratory. Recall # Z-1318-2.

REASON
Software anomaly. If the deformatter begins to process data prior to all patient result records or orders being extracted from the flat files, the remaining results or orders will not be extracted. This can result in data being processed out of sequence into the Mysis Commercial Laboratory System.

CODE
Versions 3.3.0, 3.3.1, 3.4.0 and 3.4.1a.

RECALLING FIRM/MANUFACTURER
Mysis Healthcare Systems, Inc., Plano, TX, by fax May 15, 2002.

VOLUME OF PRODUCT IN COMMERCE
7.

DISTRIBUTION
TX, FL, NY, MN, NC and PA.

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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