FDAFDA · Food and drugs·Recall number Z-0721-2017
RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System Product Usage: RayStation 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.
Published December 14, 2016 · Recall initiated: November 9, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Software anomaly; an issue was found with the proton Pencil Beam Scanning (PBS) dose calculation in RayStation 4.0, 4.5, 4.7 and 5.0. For treatment plans with a combination of range shifter, large air gap and beams that enter the patient surface at an oblique angle, the dose calculation accuracy may be less than expected.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Distributor
- US Nationwide Distribution in the states of California, Florida, Illinois, Louisiana, Michigan, New Jersey, Tennessee, Texas, Washington
- Lot
- Build numbers: 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 , 5.0.0.37 , 5.0.1.11 or 5.0.2.35
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Sweden
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