medical Class II Updated 2021-06-16

Viewray, Inc. recalls ViewRay MRIdian Linac System: Model No. 20000-01 software, C

Recalled 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.

Hazard / Issue

Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.

Issued by

FDA

Distribution: International distribution only to the countries of France, Germany, Italy, and Switzerland.
Lot/Code Info: French version of the TDS software affected serial numbers: 214, 215, 226 and 240 German or Italian versions of the TDS software affected serial numbers: 203, 232, 108 and 244
View official government recall

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