RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1),…

Is this the product you have?

• RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation 7 (RayPlan 7) and RayStation 8A (RayPlan 8A)
• 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 Versions 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
  • 5.0.2.3
  • 6.0.0.24
  • 6.1.0.26
  • 6.1.1.2
  • 6.2.0.7
  • 7.0.0.19
  • 8.0.0.61

Amount recalled

746

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
• NV
• NY
• OH
• OK
• OR
• PA
• RI
• TN
• TX
• UT
• VA
• VT
• WA
• WI

Why it was recalled

If the beam model has a highly asymmetric primary source, it is not correctly taken into account in the calculation of DMLC fields when the collimator is rotated. This could lead to potentially significant overdosage at delivery. The user must be aware of the issue to avoid incorrect dose calculations during treatment planning.

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