Reported Apr 4, 2018 · Terminated
Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11,…
Raysearch Laboratories Ab
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: RAYSEARCH LABORATORIES AB · Sveavaegen 9 · Stockholm · N/A
Is this the product you have?
Ray Station 4.9 Ray Station 5Ray Station 6 and
- Ray Station 7 Software build numbers
4.9.0.425.0.0.375.0.1.115.0.2.356.0.0.246.1.0.266.1.1.26.2.0.7 or 7.0.0.19
- UDI0735000201006820171130
- Lot codes and dates
- Software build numbers
4.9.0.425.0.0.375.0.1.115.0.2.356.0.0.246.1.0.266.1.1.26.2.0.7 or 7.0.0.19
- Software build numbers
- Amount recalled
- 2484
Where it was sold
- Nationwide
Why it was recalled
Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient.
This product could cause temporary or reversible health problems — stop using it.
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