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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Product Detail

Product Description Focal SIM Planning of radiation therapy
Recall Number Z-2002-2012
Classification Class II
Code Info Version 4.64.00 - 4.700, inclusive
Product Distributed Qty 38 units
Reason For Recall Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.

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.