Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:20245
Brand Name:RaySearch RayStation Treatment Planning System
Model:
Affected:
Software version:5.0.0.37, 5.0.1.11 and 5.0.2.35
Recalling Organisation:CARSL Consulting
30 Fulford Road
Havelock North 4130
Hastings
Contact Information:09 238 3447
Manufacturer:RaySearch Laboratories AB (publ)
Issue:An issue has been found with the treatment plan report in RayStation 5. For a treatment plan with multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set dose. The error can only be triggered when using a report template where statistics for a beam set dose are included as the last dose statistics prior to the plan dose statistics. For such a report template, all reports for multiple beam set plans would always be affected.
The user must be aware of information to avoid incorrect assessment of treatment plan dose levels. i.e Inspect all report templates that are intended to be used for plans with multiple beam sets. Make sure that "POI Dose statistics (Plan)" is included immediately before "ROI Dose statistics [Plan dose]" in the Report content area.
This issue will be resolved in the next version of RayStation, scheduled for market release Nov 2016
Recall action type:Correction
Recall action:Manufacturer to issue advice regarding use
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:7/6/2016
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