FDA Device recall Z-0676-2020
MRIdian Linac Radiation Therapy System Model 10000 and 20000
- FDA Device
- Class II
- terminated
- Published 2019-12-18
On 2019-12-18 the FDA classified a Class II recall of MRIdian Linac Radiation Therapy System Model 10000 and 20000 by Viewray, citing issue with transferring treatment regiment from one system to another. Adequate instructions for transferring treatment plan(s) are not provided within the operator's manual or wi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0676-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-03 |
| Published | 2019-12-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Viewray |
| Distribution | CA, FL, IL, MI, MO, NY, WI |
Product
MRIdian Linac Radiation Therapy System Model 10000 and 20000
Reason
Issue with transferring treatment regiment from one system to another. Adequate instructions for transferring treatment plan(s) are not provided within the operator's manual or within the software operating system.
Identifiers
| code_info | Serial Numbers: 100, 101, 102, 103, 104, 105, 107, 108, 112, 113, 201, 202, 203, 204, 205, 206, 209, 211, 213, 214, 217…Serial Numbers: 100, 101, 102, 103, 104, 105, 107, 108, 112, 113, 201, 202, 203, 204, 205, 206, 209, 211, 213, 214, 217, 221, 223, 225 Device Listing Number: D158423 and D297999 |
|---|
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 20000
FDA Device · Class II · 2019-05-08 · Viewray
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0676-2020%22
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