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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
Other
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
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