Device 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.
Z-1836-2021
Product summary
- Firm
- Viewray, Inc.
- Event
- Event 87865
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 versions
- Official record key
device-enforcement:Z-1836-2021
Official wording
Reason: Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.
Code information: 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
Distribution pattern: International distribution only to the countries of France, Germany, Italy, and Switzerland.
Derived failure modes
-
Device software or design
Software anomalies