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U.S. Department of Health and Human Services

Enforcement Report - Week of October 2, 2013

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Event Detail

Event ID 65998
Product Type Devices
Status Ongoing
Recalling Firm Elekta, Inc.
City Atlanta
State GA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-22
Initial Firm Notification of
Consignee or Public
Distribution Pattern Distributed in Puerto Rico and the states of AK, AZ, CA, CO, CT, FL, IL, IN, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, and WA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning. All versions of Monaco Class II Patient needs to be positioned as indicated by the treatment plan. 72 Z-2277-2013