FDA Device recall Z-1580-2015
ViewRay System, Radiation Therapy System
- FDA Device
- Class II
- terminated
- Published 2015-05-13
On 2015-05-13 the FDA classified a Class II recall of ViewRay System, Radiation Therapy System by Viewray, citing the software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient orientations, result….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1580-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-15 |
| Published | 2015-05-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Viewray |
| Distribution | MO |
Product
ViewRay System, Radiation Therapy System
Reason
The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient orientations, resulting in slice mismatch error.
Identifiers
| code_info | M/N 10000, S/N 100 only |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1580-2015%22
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