Reported Nov 20, 2013 · Terminated

Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0

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 Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
Lot codes and dates
    • Software version and build numbers 3.0.0.251
    • 3.5.0.16
    • 3.5.1.6
    • 4.0.0.14
    • 4.0.1.4
Amount recalled
195 units domestically

Where it was sold

Why it was recalled

Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 17, 2017 · Data as of Sep 19, 6:06 PM UTC

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