Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1465-2012

MEDITECH Anatomical Pathology Software Client Releases- Client Service Releases 5.6, 5.63, 5.64, 5.65, 6.0...

Medical Information Technology, Inc. / initiated 2012-03-30 / Terminated / root cause: software

Medical Information Technology, Inc. began a recall of 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... on . The reason FDA records is "Meditech Anatomical Pathology software is being recalled because data on a pathology specimen may be inadvertently deleted". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-1465-2012
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Medical Information Technology, Inc.
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.
Product code
JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall
Meditech Anatomical Pathology software is being recalled because data on a pathology specimen may be inadvertently deleted.
Root cause tag
software
FDA root cause
Software design
Action
MEDITECH sent a notification beginning on January 19, 2012 to customers who are LIVE with MEDITECH Client Server Anatomical Pathology 5.6 and higher. This notification was made via e-mailed task updates that informed customers of the software issues and the code corrections that are available.
Quantity in commerce
280
Distribution
Worldwide Distribution - USA Nationwide and the countries of Bahamas, Canada and United Kingdom.
Product codes and lots
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