Reported May 13, 2015 · Terminated
ViewRay System, Radiation Therapy System
Viewray Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Viewray Incorporated · 2 Thermo Fisher Way · Oakwood Village, OH · 44146-6536
Is this the product you have?
- ViewRay System, Radiation Therapy System
- Lot codes and dates
M/N 10000S/N 100 only
- Amount recalled
- 1
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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