Nov. 8, 2006 Class III Misys Healthcare Systems

Company:Misys Healthcare Systems
Date of Enforcement Report:5/16/2007
Class:lll

PRODUCT
Mysis Laboratory Blood Bank and Blood Donor Software, Recall # B-0549-07

REASON
Blood Bank software, containing a glitch or defect, was distributed.

CODE
Version 6.1 and 6.2

RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by e-mail dated November 8, 2006. Firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
246 units

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 62366 Usability Process and Documentation

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