Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1580-2015 — ViewRay System, Radiation Therapy System

U.S. FDA — Device Enforcement · United States · 2015-01-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1580-2015
Date of alert
2015-01-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Viewray Incorporated
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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