Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall RayStation

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall RayStationsee related information
Date Initiated by FirmJune 06, 2018
Create DateJuly 26, 2018
Recall Status1 Terminated 3 on April 04, 2019
Recall NumberZ-2554-2018
Recall Event ID 80515
510(K)NumberK180379 
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
ProductRayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 7.0 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.
Code Information 2.5.1.89 , 3.5.0.16 , 3.5.1.6 , 4.0.0.14 , 4.0.1.4 4.0.2.9 , 4.0.3.4 , 4.3.0.14 , 4.5.0.19 , 4.5.1.14 , 4.5.2.7 , 4.7.0.15 , 4.7.1.10 , 4.7.2.5 , 4.7.3.13 , 4.7.4.4 , 4.7.5.4 , 4.9.0.42 , 5.0.0.37 , 5.0.1.11 , 5.0.2.35, 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 7.0.0.19 .
Recalling Firm/
Manufacturer		 RAYSEARCH LABORATORIES AB
Sveavagen 9
Stockholm Sweden
Manufacturer Reason
for Recall		The firm has learned that some RayStation/RayPlan users have commissioned machines with erroneous Beam profile correction parameters. These parameters affect the dose calculated in corners of large or off-axis fields. This effect cannot be seen in the Beam Commissioning module and dose in large or off-axis fields needs to be validated using the Beam 3D Modeling module in RayPhysics/RayPlan Physics. The user must be aware to avoid incorrect dose calculations during treatment planning.
FDA Determined
Cause 2		Software design
ActionOn June 6, 2018, the firm issued an Urgent Field Safety Notice, Medical Device Correction letter to affected customers via email. The notice was a reminder to follow the instructions listed in the product documentation when creating a photon beam model in RayStation/RayPlan. ACTIONS TO BE TAKEN BY THE USER " Always validate the beam model for all clinically relevant fields, including, but not limited to, large and off-axis fields, before the system is used to create clinical treatment plans. " Carefully review all beam model parameters before commissioning. " Be aware that the Beam profile correction values may need to be adjusted in order to correctly model the primary collimator that limits the dose in the corners of large or off-axis fields. " Review any existing photon beam models to ensure that the actions above have been properly performed. Please educate physics staff about these user responsibilities. Inspect your product and identify all installed units with the above software version number(s), then confirm that you have read and understood this notice by replying to the notification email. Safe use relies on careful validation of the beam model for all clinically relevant fields before the system is used to create clinical treatment plans. This information is already present in the Instructions For Use, the Reference Manual and the RayPhysics/RayPlan Physics Manual for the existing product versions. To further reduce the risk of using improper beam models, the safety warnings within the product documentation will be updated in the next version of RayStation/RayPlan, scheduled for market release in June 2018.
Quantity in Commerce718
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MUJ
-
-