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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Event Detail

Event ID 64213
Product Type Devices
Status Ongoing
Recalling Firm Elekta, Inc.
City Atlanta
State GA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-18
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution including TX

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Elekta, Apex add-on Micro MLC, collimator for radiation therapy. 152652 Class II If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view restrictions dialog box only shows the top 12 restrictions. 1 Z-0885-2013