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U.S. Department of Health and Human Services

Enforcement Report - Week of February 27, 2013

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Product Detail

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

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.
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