FDA Device recall Z-1836-2021
ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiat…
- FDA Device
- Class II
- terminated
- Published 2021-06-16
On 2021-06-16 the FDA classified a Class II recall of ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiat… by Viewray, citing software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1836-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-05-04 |
| Published | 2021-06-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Viewray |
| Distribution | n/a |
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.
Reason
Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.
Identifiers
| code_info | French version of the TDS software affected serial numbers: 214, 215, 226 and 240 German or Italian versions of the…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1836-2021%22
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