Misys Healthcare Systems Class II

Company: Misys Healthcare Systems
Date of Enforcement Report: 4/9/03
Class: II

PRODUCT
Misys Laboratory System Version 5.3. Recall # Z-0670-03.

REASON
Software anomaly. The HIDE command used to suppress suspected individual microbiology observations does not work in GUI inquiry.

CODE
Version 5.3.

RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by fax on February 19, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
464.

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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IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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