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U.S. Department of Health and Human Services

Class 2 Device Recall MEDITECH Anatomical Pathology Software

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  Class 2 Device Recall MEDITECH Anatomical Pathology Software see related information
Date Initiated by Firm March 30, 2012
Date Posted April 26, 2012
Recall Status1 Terminated 3 on August 13, 2014
Recall Number Z-1465-2012
Recall Event ID 61510
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
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.
Code Information 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
Recalling Firm/
Manufacturer		 Medical Information Technology, Inc.
Meditech Circle
Westwood MA 02090
For Additional Information Contact Paul Berthiaume
781-821-3000 Ext. 5742
Manufacturer Reason
for Recall		 Meditech Anatomical Pathology software is being recalled because data on a pathology specimen may be inadvertently deleted.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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