Misys Healthcare Systems Class II

Company: Misys Healthcare Systems
Date of Enforcement Report: 12/10/03
Class: II

PRODUCT
Misys Laboratory System. Recall # Z-0151-04.

REASON
Software defect causes orders to be lost under certain conditions of use. A typographical error at the Accept/Modfy/Reject prompt will cause the order not to be processed by the system.

CODE
Versions 5.2, 5.23, 5.3 up to 5.3.2.

RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by fax on July 7, 2003. FDA initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
473.

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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