RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3,…

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• RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0 -
• Product UsageRayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system

Lot codes and dates

• Software Version Numbers
  • 4.0.0.14
  • 4.0.1.4
  • 4.0.2.9
  • 4.0.3.4
  • 4.5.0.19
  • 4.5.1.14
  • 4.5.2.7
  • 4.7.0.15
  • 4.7.1.10
  • 4.7.2.5
  • 4.7.3.13
  • 4.7.4.4
  • 4.7.5.4
  • 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
  • 6.3.0.6
  • 7.0.0.19
  • 8.0.0.61
  • 8.0.1.10
  • 8.1.0.47
  • 8.1.1.8
  • 8.1.2.5
  • or 9.0.0.113

Amount recalled

956 Devices/Licences

Where it was sold

• Nationwide
• AL
• AR
• AZ
• CA
• CO
• CT
• DC
• DE
• FL
• GA
• HI
• ID
• IL
• LA
• MA
• MD
• ME
• MI
• MO
• MS
• MT
• NC
• NJ
• NY
• OH
• OK
• OR
• PA
• RI
• TN
• TX
• UT
• VA
• VT
• WA
• WI

Why it was recalled

Editing a static arc beam may unexpectedly set the MU of the beam to its initial default value of 200 MU. If the bug is triggered, the dose is invalidated and needs to be recalculated before the plan can be approved or exported.

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