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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 62433
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
Other
Distribution Pattern Nationwide Distribution including 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
Focal SIM Planning of radiation therapy Version 4.64.00 - 4.700, 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 units Z-2002-2012
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