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U.S. Department of Health and Human Services

Enforcement Report - Week of October 2, 2013

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Product Detail

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

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 Letter
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.