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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Product Detail

Product Description Elekta, Apex add-on Micro MLC, collimator for radiation therapy.
Recall Number Z-0885-2013
Classification Class II
Code Info 152652
Product Distributed Qty 1
Reason For Recall 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.

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