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U.S. Department of Health and Human Services

Class 2 Device Recall RayStationTherapy Treatment Planning System

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  Class 2 Device Recall RayStationTherapy Treatment Planning System see related information
Date Initiated by Firm February 10, 2016
Date Posted May 25, 2016
Recall Status1 Terminated 3 on April 24, 2017
Recall Number Z-1712-2016
Recall Event ID 73575
510(K)Number K141860  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment planning and analysis of radiation therapy.
Code Information,,,,,,,,,,,,, or
Recalling Firm/
Sveavaegen 9
Stockholm Sweden
Manufacturer Reason
for Recall
A software issue with editing tools that use the left mouse button held down, for drawing in and interacting with the patient views and beams eye views. The views can become unsynchronized with the stored data if simultaneously right clicking, pressing Ctrl-S or Ctrl-Z while the left mouse button is held down. This bug does not affect dose computations, which are based on the stored system state.
FDA Determined
Cause 2
Action On February 10, 2016, RaySearch Laboratories distributed Field Safety, Medical Device Correction notices and Reply Forms to their customers via email. To determine if the software version you are using is affected, open the About RayStation dialog in the RayStation application and check if the build number reported. This bug does not affect dose computations. Dose is always computed based on the stored system state. Actions to be taken by the user include the following: Always release the left mouse button before using other keys or mouse buttons, If the warning message "Temporary items should not be visible on approval" is displayed or if there is some suspicion that the bug may have triggered in structure definition, either review the structures in the Plan approval dialog, or close and reload the patient case and review the structures again. All customers should educate planning staff and all users about this workaround. All customers are advised to inspect product and identify all installed units with the referenced software version number, then confirm that you have read and understood the notice by completing and returning the reply form. The completed reply form should be returned to Freddie Cardel, freddie.cardel@raysearchlabs.com, fax 888-501-7195. Customers with questions can call 1-877-778-3849, available east coast business hours all US working days.
Quantity in Commerce 1,264 Total units (552 units domestically & 711 units internationally)
Distribution **Domestic** AR, AZ, CA, CT, CO, DE, FL, GA, IL, LA, MI, MD, MS, MA, NY, NV, NJ, OH, OR, PA, NC, RI, TN, WA & Washington D.C; **Internationally** Algeria, Australia, Austria, Belgium, Canada, China, France, French Polynesia, Germany, Iran, Italy, Japan, Netherlands, New Zealand, Norway, Republic of Korea, Spain, Sweden, Switzerland, Thailand & United Kingdom
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = RAYSEARCH LABORATORIES AB