Viewray, Inc. Recall 87865
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.
Viewray, Inc. Recall 87865 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1836-2021 |
| Event ID | 87865 |
| Event 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. |
| Product Type | Devices |
| Distribution | International distribution only to the countries of France, Germany, Italy, and Switzerland. |
| Quantity | 8 versions |
| Recall Reason | Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software. |
| Device Classification | 20210616 |
| Device 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 |
| Center Classification Date | 20210609 |
| Recall Initiation Date | 20210504 |
| Recalling Firm | Viewray, Inc. |
| Initial Notification | |
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