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RAYSEARCH LABORATORIES AB recalls 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
Recalled April 4, 2018 · FDA recall Z-1275-2018 · RAYSEARCH LABORATORIES AB
Hazard
Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient. · FDA Class II
Units
2484
Sold at
Nationwide
Description
Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient.
Product
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
Manufacturer(s)
RAYSEARCH LABORATORIES AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →