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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Event Detail

Event ID 62434
Product Type Devices
Status Ongoing
Recalling Firm Elekta, Inc.
City Norcross
State GA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-21
Initial Firm Notification of
Consignee or Public
Distribution Pattern US Nationwide Distribution - including the states of: CA, CT, FL, IL, IN, KY, MI, MN, MO, NJ, NY, NC, OH, OK, OR, PA, WA, and WI

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Monaco Product Usage: Planning of radiation therapy Version 3.10.00 - 3.20.00, inclusive Class II Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports. 38 Z-2007-2012