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Elekta, Inc. recalls Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radia
Recalled March 20, 2013 · FDA recall Z-0931-2013 · Elekta
Hazard
The DICOM tags do not contain sufficient information for XVI to identify the different volumes that have the same name. · FDA Class II
Units
164
Sold at
Nationwide Distribution-DC, Puerto Rico and the states of AL, AK, AZ, CA, CO, CT, FL, GA, IL, IA, KY, MD, MA, MI, MN, MS, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, and WI.
Description
The DICOM tags do not contain sufficient information for XVI to identify the different volumes that have the same name.
Product
Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
Manufacturer(s)
Elekta, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →