May

2006

Class II Misys Healthcare Systems

Company: Misys Healthcare Systems,
Date of Enforcement Report:5/17/2006
Class:lI

PRODUCT
Misys Laboratory Blood Bank Module, Version 6.1, Recall # B-1065-6

REASON
Defects in the design of software could result in data being out of sync with the accession number, patient and/or units displayed on the screen.

CODE
Version 6.1

RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by telephone and electronic mail dated March 15, 2006, firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1 unit

DISTRIBUTION
Nationwide and Internationally

About the author

Amy Sellers

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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Class II Misys Healthcare Systems

Amy Sellers

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