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Elekta, Inc. recalls DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose deli
Recalled March 5, 2014 · FDA recall Z-0978-2014 · Elekta
Hazard
It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems · FDA Class II
Units
35 units
Sold at
US Nationwide Distribution in the states of CT, FL, GA, IA, MO, NY, ND, OK, RI, TX, VA, WA
Description
It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems
Product
DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so that adjacent non-diseased tissues are spared to the extent possible.
Manufacturer(s)
Elekta, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →