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

___________________________________

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.