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Viewray, Inc. recalls ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning ex
Recalled June 16, 2021 · FDA recall Z-1836-2021 · Viewray
Hazard
Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software. · FDA Class II
Units
8 versions
Sold at
International distribution only to the countries of France, Germany, Italy, and Switzerland.
Description
Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.
Product
ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated, in conjunction with the ViewRay System, an MRI image-guided radiation therapy system.
Manufacturer(s)
Viewray, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →