Recall archive
53 recalls · page 2 of 3
Reported Mar 18, 2020
RayStation/RayPlan 8A, Build Number 8.0.0.61, stand-alone software treatment planning system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 5, 2020
RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — Three issues found: i) The Map ROI options in the ROI list in the Structure Definition module may generate unintended ROI geometries ii) Elekta guard…
FDA (openFDA device enforcement)
Reported Jan 1, 2020
RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — Editing a static arc beam may unexpectedly set the MU of the beam to its initial default value of 200 MU. If the bug is triggered, the dose is…
FDA (openFDA device enforcement)
Reported Jul 10, 2019
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong
FDA (openFDA device enforcement)
Reported Jan 2, 2019
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — Isocenter shifts when using dose tracking in RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7…
FDA (openFDA device enforcement)
Reported Nov 7, 2018
RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and…
FDA (openFDA device enforcement)
Reported Aug 1, 2018
RayStation 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,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — The firm has learned that some RayStation/RayPlan users have commissioned machines with erroneous Beam profile correction parameters. These…
FDA (openFDA device enforcement)
Reported Jul 25, 2018
RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — If the beam model has a highly asymmetric primary source, it is not correctly taken into account in the calculation of DMLC fields when the…
FDA (openFDA device enforcement)
Reported Jul 4, 2018
RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 Product Usage: Usage: RayStation is a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — The dose calculation accuracy may in some situations be less than expected. The user must be aware in order to avoid incorrect dose calculations…
FDA (openFDA device enforcement)
Reported Apr 4, 2018
Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient.
FDA (openFDA device enforcement)
Reported Jan 24, 2018
RayStation Product Usage: is a software system designed for treatment planning and analysis of radiation therapy. The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in…
FDA (openFDA device enforcement)
Reported Apr 19, 2017
Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — An error in NVIDIA GPU (Graphics Processing Unit) card drivers can occur for certain software programs. In a non-standard Citrix environment where…
FDA (openFDA device enforcement)
Reported Dec 14, 2016
Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — An error may occur with the display of dose computed on images other than the planning CT (auxiliary CT) when using multiple patient cases in…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 19, 2016
Radiation Therapy Treatment Planning System, Model 5.0
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set…
FDA (openFDA device enforcement)
Reported Oct 12, 2016
RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radiation Therapy Treatment Planning System…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand · Reason for recall — RaySearch became aware of the problem as it was discovered in cooperation with a customer experimenting with the dose calculation on a phantom. The…
FDA (openFDA device enforcement)
Reported Jul 27, 2016
RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation Therapy…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — An issue was found with the evaluation of biological clinical goals in RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7…
FDA (openFDA device enforcement)
Reported Jun 1, 2016
RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Sep 23, 2015
Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment planning…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Sep 2, 2015
RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are used. The ROI contraction tool uses six…
FDA (openFDA device enforcement)
Reported Jun 3, 2015
RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: RayStation is a software system…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand · Product · Product details · Reason for recall — RaySearch Laboratories AB became aware of an issue with the dose calculation for some imported VMAT plans where controls points are defined with wide…
FDA (openFDA device enforcement)
Reported Apr 1, 2015
RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — An issue with photon dose calculation for DMLC (Dynamic MLC) plans for machines where the MLC is positioned above the jaws, e.g. some Elekta linacs.…
FDA (openFDA device enforcement)
Reported Jun 25, 2014
RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric…
FDA (openFDA device enforcement)
Reported Apr 30, 2014
RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand · Product · Product details · Reason for recall — RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0" software due to dose miscalculations for…
FDA (openFDA device enforcement)
Reported Apr 9, 2014
RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — Potential for dose errors due to software program errors.
1 more product in this recall
FDA (openFDA device enforcement)
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