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U.S. Department of Health and Human Services

Enforcement Report - Week of May 29, 2013

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Event Detail

Event ID 65158
Product Type Devices
Status Ongoing
Recalling Firm Medical Information Technology, Inc.
City Westwood
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-07
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution - USA, including Puerto Rico and the country of Canada.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
MEDITECH Bi-Directional interactive Communication Analyzer Interface; Integrates with MEDITECH's Laboratory Information System (LIS) with Other Vendor systems to manage the transfer of patient results and demographic information. Magic Releases 5.41, 5.52. 5.53, 5.62, 5.63, 5.64 and Client Server Releases 5.64, 5.65, 6.05, 6.06, 6.07 Class II Incorrect transmission of laboratory results. 56 devices Z-1365-2013