Viewray Incorporated recalls ViewRay System, Radiation Therapy System
- Recall date
- January 15, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1580-2015
- FDA classification
- Class II
- Brand / firm
- Viewray Incorporated
- Sold / distributed
- US distribution to MO.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
ViewRay System, Radiation Therapy System
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