FDA-Device2018-04-04Class II
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, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or 7.0.0.19 UDI: 0735000201006820171130
Hazard
Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient.
Sold states
Nationwide
Affected count
2484
Manufactured in
Sveavaegen 9, Stockholm, Sweden
Products
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, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or 7.0.0.19 UDI: 0735000201006820171130
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1275-2018More RAYSEARCH LABORATORIES AB recalls
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