RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment 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 May 27, 2015).
- Recall Initiated
- May 8, 2015
- Posted
- May 27, 2015
- Terminated
- April 11, 2017
- Recall Number
- Z-1679-2015
- Quantity
- Domestic: 539 units
- Official Source
- View on FDA website ↗
Reason for Recall
RaySearch Laboratories AB became aware of an issue with the dose calculation for some imported VMAT plans where controls points are defined with wide gantry angle spacing.
Distribution
US Nationwide Distribution
Lot / Code Info
Software Version (Build numbers) 2.5.1.89, 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, or 4.0.3.4
Root Cause
Software Design Change
Action Taken
RaySearch sent a Device Correction letter dated May 8, 2015 via e-mailed to their customers. The letter identified the affected product, problem, actions to be taken by users and contact information.
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