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Elekta, Inc. recalls Focal SIM Planning of radiation therapy
Recalled July 18, 2012 · FDA recall Z-2002-2012 · Elekta
Hazard
Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports. · FDA Class II
Units
38 units
Sold at
Nationwide Distribution including CA, CT, FL, IL, IN, KY, MI, MN, MO, NJ, NY, NC, OH, OK, OR, PA, WA, and WI.
Description
Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.
Product
Focal SIM Planning of radiation therapy
Manufacturer(s)
Elekta, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →