RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation Therapy…

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• RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation Therapy Treatment Planning System --- designed for treatment planning and analysis of radiation therapy, provides treatment unit set up parameters and estimates dose distributions.

Lot codes and dates

• Software build numbers
  • 3.0.0.251
  • 3.5.0.16
  • 3.5.1.6
  • 4.0.0.14
  • 4.0.1.4
  • 4.0.2.9
  • 4.0.3.42
  • 4.5.0.19
  • 4.5.1.14
  • 4.5.2.7
  • 4.7.0.15
  • 4.7.1.10
  • 4.7.2.5
  • 4.7.4.4
  • 4.7.5.4
  • 5.0.0.37
  • 5.0.1.11 and 5.0.2.35

Amount recalled

US: 170 units

Where it was sold

• CA
• CT
• DE
• FL
• HI
• ME
• MO
• NY
• OH
• TX
• WA

Why it was recalled

An issue was found with the evaluation of biological clinical goals in RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5. Biological clinical goals for an adapted plan based on another planning CT than the original planning CT will show incorrect values. -- To the best of the firm's knowledge, the issue has not caused any patient mistreatment or other incidents. However, the user must be aware of the following information to avoid incorrect plan evaluation during treatment planning.

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