May

2012

Cl ll MEDITECH Anatomical Pathology Software

Company:Medical Information Technology, Inc.
Date of Enforcement Report 5/16/12
Class ll:

PRODUCT
MEDITECH Anatomical Pathology Software Client Releases- Client Service Releases 5.6, 5.63, 5.64, 5.65, 6.0, 6.04, 6.05, 6.06, 6.1, 6.12 and 6.13 Product Usage: Meditech Anatomical Pathology Software records, stores, codes, searches and provides reports for pathology cases. It enables pathology staff and other personnel to access related findings in real time. Recall # Z-1465-2012

REASON
Meditech Anatomical Pathology software is being recalled because data on a pathology specimen may be inadvertently deleted.

RECALLING FIRM/MANUFACTURER
Medical Information Technology, Inc., Westwood, MA, by e-mail beginning on January 19, 2012. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
280 units

DISTRIBUTION
Nationwide, Bahamas, Canada and United Kingdom

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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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Cl ll MEDITECH Anatomical Pathology Software

Amy Sellers

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