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.
This recall has been terminated (originally issued November 9, 2016).
- Recall Initiated
- November 9, 2016
- Terminated
- June 11, 2019
- Recall Number
- Z-0721-2017
- Quantity
- US: 66 units
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Nationwide Distribution in the states of California, Florida, Illinois, Louisiana, Michigan, New Jersey, Tennessee, Texas, Washington
Lot / Code Info
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
Root Cause
Software design
Action Taken
Ray Search sent an Urgent Field Safety Notice Medical Device Correction letter (dated 11/8/2016) via e-mailed to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to Inspect their product and identify all installed units with the above software version number, then confirm you have read and understood this notice (contact information included).