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Viewray Incorporated recalls ViewRay System, Radiation Therapy System
Recalled May 13, 2015 · FDA recall Z-1580-2015 · Viewray Incorporated
Hazard
The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient orientations, resulting in slice mismatch error. · FDA Class II
Units
1
Sold at
US distribution to MO.
Description
The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient orientations, resulting in slice mismatch error.
Product
ViewRay System, Radiation Therapy System
Manufacturer(s)
Viewray Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →