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 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
  • UDI0735000201006820171130
Lot codes and dates
  • 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
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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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 13, 2020 · Data as of Sep 19, 5:20 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.