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U.S. Department of Health and Human Services

Enforcement Report - Week of September 19, 2012

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Event Detail

Event ID 62915
Product Type Devices
Status Ongoing
Recalling Firm Elekta, Inc.
City Norcross
State GA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-27
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution including DC & MD

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated. 152599 and 152678 Class II Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex. 2 Z-2340-2012