26
Oct
2005

Misys Healthcare Systems. Class II

0

Company: Misys Healthcare Systems.
Date of Enforcement Report: 9/29/2005
Class:II

PRODUCT
Misys Laboratory version 6.1 – Microbiology Module, Recall # Z-0088-06

REASON
Software problem when the user has indicated to enter a coded comment instead of using the defined keyboard, then enters 100,000 the system will file the number 100 instead of number 100,000.

CODE
All serial numbers for these models

RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by telephone, e-mails and Product Safety Notice dated September 29, 2005. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
67 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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