Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years. 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.
Recall
- Recall Number
- Z-2324-2012
- Event Number
- 62967
- Firm
- RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden
- FEI Number
- 3007774465
- Product Code
- MUJ
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- May 9, 2012
- Posted
- September 6, 2012
- Terminated
- January 25, 2013
Description
Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years. 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.
The firm decided to recall when an issue was found with the dose calculation in RayStation 2.5, Raystation 2.5.1. The problem has not caused any patient mistreatment or other incidents. However, the user must be aware of this information to avoid incorrect dose calculations during treatment planning. The dose calculation is not correctly normalized in the unusual case of preventing the optimizatio
The firm, RaySearch Laboratories, sent an "Urgent Field Safety Notice, Medical Device Correction" letter dated May 9, 2012 to its customers. The letter describes the product, problem and actions to be taken. The letter informed the customers that the "workaround is to not use segment MU optimization" and that there "is in general no need to manually adjust the segment shapes to such an extent there is need for a separate optimization of the segment MU." Additionally, the customers were instructed -Do not uncheck the "Segment shapes" check box; educate planning staff and all users about this workaround; inspect your product and identify all installed units with the noted software version numbers; and complete and return the Reply Form via fax to: RaySearch Americas Inc. at 888-501-7195; email: [email protected] and/or email to: Raysearch Laboratories AB at [email protected]. For further information and return of the Reply Form contact For the Americas: Director of Customer Support, RaySearch Americas at +1877 778 3849 or [email protected]; and For Europe, Asia and rest of the world: Director of Service, RaySearch Laboratories AB at +46 8 5450 6130 or [email protected].
Worldwide distribution: USA (nationwide) including states of: FL, MA, NJ, and NY; and countries of: Canada Germany, Netherlands and Switzerland.
19 units