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U.S. Department of Health and Human Services

Enforcement Report - Week of February 27, 2013

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Event Detail

Event ID 64328
Product Type Devices
Status Ongoing
Recalling Firm Elekta, Inc.
City Atlanta
State GA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-11
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide Distribution-including the states of AK, CA, FL, NJ, NC, OH, OR, TN, TX, WA, and WI.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Monaco RTP System. Radiation treatment planning. Versions 3.20.00 and 3.20.01 Class II The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle. 13 Z-0841-2013
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