CLASS II Device recall · Reported 13 May 2015 · FDA Enforcement Report
System, Radiation Therapy System recalled by Viewray Incorporated
Viewray Incorporated is recalling ViewRay System, Radiation Therapy System, distributed in Missouri. The recall was initiated on 15 Jan 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1580-2015
- FDA event ID
- 71050
- Recalling firm
- Viewray Incorporated, Oakwood Village, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jan 2015
- FDA classified
- 5 May 2015
- Reported
- 13 May 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 15 Jan 2015 | Recall initiated by company | |
| 5 May 2015 | Classified by FDA | +110 days |
| 13 May 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
ViewRay System, Radiation Therapy System
Where it was distributed
US distribution to MO.
Questions about this recall
Is System, Radiation Therapy System recalled?
Yes. Viewray Incorporated recalled System, Radiation Therapy System on 15 Jan 2015. The recall is Class II and its status is Terminated. Recall number Z-1580-2015.
Why was it recalled?
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.
Which lots are affected?
M/N 10000, S/N 100 only
Where was it sold?
US distribution to MO.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Device | CLASS II | MRIdian ViewRay Radiation Therapy System recalled | Viewray Incorporated | Device Malfunction | Nationwide |
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