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FDAJanuary 26, 2018device

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient.

What to do

FDA enforcement status: Terminated

Brands named

raysearch laboratories abraysearchraysearch laboratories

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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