Radiation Therapy Treatment Planning System software 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.
This recall has been terminated (originally issued September 17, 2015).
- Recall Initiated
- May 29, 2015
- Posted
- September 17, 2015
- Terminated
- March 13, 2017
- Recall Number
- Z-2785-2015
- Quantity
- 20 devices
- Official Source
- View on FDA website ↗
Reason for Recall
An error caused by a floating point precision problem tends to cause a problem with the display of isodose lines for dose and dose difference and color tables for dose, dose difference and PET images
Distribution
Worldwide Distribution: US (nationwide) to state of WA; and countries of: France, Sweden, Austria, Spain, Germany, Italy, UK, New Zealand.
Lot / Code Info
software build numbers are 4.7.0.15 or 4.7.1.10
Root Cause
Software design
Action Taken
The firm, RaySearch Laboratories, distributed a "Field Safety Notice, Medical Device Correction #7106" notice dated May 29, 2015,and reply forms to their customers via email. The notice describes the product, problem and actions to be taken. The Customers were provided a workaround as a temporary fix. Customers were also instructed to educate all users, inspect your product and identify all installed units, confirm you have read and understood the notice by contacting Quality and Regulatory Affairs Manager; and complete and return the reply form via email to freddie.cardel@raysearchlabs.com or by fax to 888-501-7195. The solution will be resolved in the next version of RayStation, scheduled for release in June 2015. Customers were advised to share the notice to all those who need to be aware within the organizations. Customers can contact Quality and Regulatory Affairs Manager at +46 8 510 530 12 or via email at david.hedfors@raysearchlabs.com.