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.
Reported: June 16, 2021 Initiated: May 4, 2021 #Z-1836-2021
Product Description
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.
Reason for Recall
Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.
Details
- Recalling Firm
- Viewray, Inc.
- Units Affected
- 8 versions
- Distribution
- International distribution only to the countries of France, Germany, Italy, and Switzerland.
- Location
- Mountain View, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Viewray, Inc.. Units affected: 8 versions.
Why was this product recalled? ▼
Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 16, 2021. Severity: Moderate. Recall number: Z-1836-2021.
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