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U.S. Department of Health and Human Services

Enforcement Report - Week of September 19, 2012

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Product Detail

Product Description 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.
Recall Number Z-2340-2012
Classification Class II
Code Info 152599 and 152678
Product Distributed Qty 2
Reason For Recall Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex.

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 Other
Distribution Pattern Nationwide Distribution including DC & MD