Recall Z-1836-2021 ยท MUJ System, Planning, Radiation Therapy Treatment
Viewray, Inc.
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 ther
| Date | May 4, 2021 |
| Status | Terminated |
| Reason | Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software. |
| Root cause | Software design |
| Action | On May 2021, ViewRay issued an "Urgent Medical Device Correction" notification to all affected consignees via E-Mail. All affected consignees were outside of the US. In addition to informing consignees about the recall, ViewRay asked customers to take the following actions: 1. We will provide an update to customers when new information is available. Until that time: 2. Customers should be aware of these software anomalies and the behavior of the system described in this letter. 3. Please promptly complete and return the enclosed Customer Response Form to acknowledge receipt of this notific |
| Quantity | 8 versions |
| Distribution | International distribution only to the countries of France, Germany, Italy, and Switzerland. |
| FDA record | Open on fda.gov |