FDA Device recall Z-1251-2019
MRIdian Linac Radiation Therapy System, Model 20000
- FDA Device
- Class II
- terminated
- Published 2019-05-08
On 2019-05-08 the FDA classified a Class II recall of MRIdian Linac Radiation Therapy System, Model 20000 by Viewray, citing A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1251-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-18 |
| Published | 2019-05-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Viewray |
| Distribution | FL, IL, MI, MO, NY, WI |
Product
MRIdian Linac Radiation Therapy System, Model 20000.
Reason
A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.
Identifiers
| code_info | Serial Numbers 101,107, 201, 202, 203, 204, 205, 206, 209, 211, 213, 214, 217, 221, 223, 225, 228. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1251-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.