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.
Other recalls by Viewray
- 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 · 2021-06-16 · Viewray - ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amp…
FDA Device · Class II · 2020-12-02 · Viewray - ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input…
FDA Device · Class II · 2020-12-02 · Viewray - ViewRay System: Model No. 10000 and 20000 for radiation treatment
FDA Device · Class II · 2020-05-06 · Viewray - MRIdian Linac Radiation Therapy System Model 10000 and 20000
FDA Device · Class II · 2019-12-18 · Viewray
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.