ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended recall — FDA Z-1836-2021
Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.
Overview of recall records associated with Viewray, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 6.
Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.
There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user.
There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user.
Registering dose and structures in the treatment delivery workflow could result in an alignment discrepancy between the imported previously delivered dose and the displayed patient anatomy…
Issue with transferring treatment regiment from one system to another. Adequate instructions for transferring treatment plan(s) are not provided within the operator's manual or within the…
A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.
This page summarizes recall records in which the official source identifies Viewray, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.