RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden Recalls
Showing 1-20 of 24 recalls
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, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or 7.0.0.19 UDI: 0735000201006820171130
Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient.
On January 26, 2018 RaySearch Laboratories AB sent Field Safety Notice, Medical Device Correction #25955 to each customer via e-mail. Customers were advised of the following: be aware that Center Beam in Field affects all beams that share the same isocenter and that apertures may be modified in a way not intended; do not use Center Beam in Field after having created an opposed beam. If an opposed beam has been created, delete the opposed beam and use Center Beam in Field on the remaining beam. Then recreate the opposed beam; please educate planning staff and all users about this workaround; inspect your product and identify all installed units with the above software version number(s), then confirm you have read and understood this notice by replying to the notification via email, fax or by calling local support. Customers with questions were instructed to contact David Hedfors via e-mail at david.hedfors@raysearchlabs.com
Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 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
An error in NVIDIA GPU (Graphics Processing Unit) card drivers can occur for certain software programs. In a non-standard Citrix environment where the GPU settings are configured with a virtual Citrix graphics board (graphics card) an erroneous calculation may be allowed.
RaySearch Laboratories sent a Field Safety Notice dated January 18, 2017, to their customers via email. ACTIONS TO BE TAKEN BY THE USER include: 1) Verify the GPU settings on each of the Citrix XenApp servers according to the instructions in this section. A correct configuration of the RayStation GPU settings will show a graphics board that has been verified by RaySearch. The graphics boards that are verified for operation are listed in the section "Graphics card (GPU) for accelerated computations" in the System Environment Guidelines. 2) Check that displayed graphics board in the GPU Settings dialog is listed as verified for operation according to the section "Graphics card (GPU) for accelerated computations" in the System Environment Guidelines. The following figure shows an example of a correct installation. If the graphics board is not verified for operation according to the System Environment Guidelines, the installation is incorrect. In this case, disable GPU computation and contact RaySearch Support. 3) Check if "Citrix Systems Inc. Display Driver" is displayed instead of the graphics board name. If so, the Citrix XenApp installation is incorrect. If an incorrect installation of Citrix XenApp is detected: a. Set the Citrix XenApp server to maintenance mode or disable GPU computation on the erroneous server; b. Contact RaySearch Support for instructions on how to resolve the issue. Customers are advised to pass a copy of the safety notice and educate IT staff and all users that are members of the RayStation-Administration user group (or equivalent) about this (i.e., users with the permission to change GPU settings). Inspect your product and identify all installed units with the above software version number(s), then confirm you have read and understood this notice by completing and returning the last page via email or fax to: freddie.cardel@raysearchlabs.com, fax 888 501 7195.
RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System 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 user
Software anomaly; an issue was found with the proton Pencil Beam Scanning (PBS) dose calculation in RayStation 4.0, 4.5, 4.7 and 5.0. For treatment plans with a combination of range shifter, large air gap and beams that enter the patient surface at an oblique angle, the dose calculation accuracy may be less than expected.
Ray Search sent an Urgent Field Safety Notice Medical Device Correction letter (dated 11/8/2016) via e-mailed to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to Inspect their product and identify all installed units with the above software version number, then confirm you have read and understood this notice (contact information included).
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 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 n
RaySearch became aware of the problem as it was discovered in cooperation with a customer experimenting with the dose calculation on a phantom. The correction concerns two issues found with the dose calculation when using a region of interest (ROI) of type Fixation or Support with material override within the patient outline (External ROI) in RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0).
RaySearch sent a Field Safety Notice, on September 1, 2016, (RSL-D-61-301, dated 9/5/2016), was sent by e-mail to all affected customers. ACTIONS TO BE TAKEN BY THE USER Do not use ROIs of type Fixation or Support within the patient outline. Always use other ROI types for material override within the External ROI. A small overlap with the External ROI is acceptable if the Fixation or Support ROI is mainly outside the External ROI. Please educate planning staff and all users about this workaround. Inspect your product and identify all installed units with the above software version number, then confirm you have read and understood this notice (contact information below). SOLUTION A correction of these issues will be available in the next version of RayStation, scheduled for market release in December 2016. In the meantime, this field safety notice is distributed to all customers. Until a corrected version has been installed, all affected users must maintain awareness of this field safety notice. TRANSMISSION OF THIS FIELD SAFETY NOTICE This notice needs to be passed on to all those who need to be aware within your organization. Please maintain awareness of this notice as long as this version of RayStation is in use to ensure effectiveness of the workaround.
Radiation Therapy Treatment Planning System 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.
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 RayStation 5. If a CT image set with the same Frame of Reference as the displayed auxiliary CT set exists in another case, the dose display may be incorrect. When the error occurs, the display of dose in patient views, including the maximum dose position, the dynamic isodose lines and the dose grid may be incorrect. The dose value normally displayed in the upper left corner when pointing in the 2D view may be incorrect or missing.
On October 11, 2016 RaySearch Laboratories distributed a Field Safety Notice, Medical Device Correction #13529 to customers via email. Customers were instructed to take caution when a patient has multiple cases. The following may be incorrect if there are image sets that shre the same Frame of Reference residing in different cases: *Display of evaluation dose computed on another CT image set and *Dose tracking fraction dose and deformed dose. Until a corrected version has been installed, all affected users must maintain awareness of this field safety notice. In these cases, the display of the dose values in the 2D view, including the dose value shown when pointing in the view, maximum dose position, dynamic isodose lines and dose grid display may be incorrect. Customers are encouraged to educate staff and all users about this. For regulatory information, please contact David Hedfors, at +46 8 510 530 12 or david.hedfors@raysearchlabs.com.
RayStation Product Usage: 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.
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 the QA module may be computed for a different setup than what is used for QA measurements. This could result in an incorrect dosage being provided to a patient.
Ray Search sent a Field Safety Notice letter dated July 14, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter included a response form with instructions for workarounds until the software is corrected.
RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation Therapy Treatment Planning System --- designed for treatment planning and analysis of radiation therapy, provides treatment unit set up parameters and estimates dose distributions.
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 and RayStation 5. Biological clinical goals for an adapted plan based on another planning CT than the original planning CT will show incorrect values. -- To the best of the firm's knowledge, the issue has not caused any patient mistreatment or other incidents. However, the user must be aware of the following information to avoid incorrect plan evaluation during treatment planning.
RaySearch Laboratories AB sent Field Safety Notice/Medical Device Correction #11905 Letter (RSL-D-61-298, dated 7/1/2016) to end users via e-mail on 7/1/2016. The letter informs end users of the issue and provides actions to be taken by the users (work around).
Radiation Therapy Treatment Planning System, Model 5.0
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 dose. The error can only be triggered when using a report template where statistics for a beam set dose is included as the last dose statistics prior to the plan dose statistics.
On May 19th, 2016, RaySearch Laboratories distributed Field Safety Notice, Medical Device Correction notices and reply forms to their customers via email. Actions to be taken by the customer include: 1) Inspect all report templates that are intended to be used for plans with multiple beam sets. 2) Make sure that POI Dose statistics (Plan) is included immediately before ROI Dose statistics [Plan dose] in the Report content area. 3) Please educate planning staff and all users about this workaround. 4) Inspect your product and identify all installed units with the above software version number. Finally, complete and return the reply form via email to: freddie.cardel@raysearchlabs.com or by fax to: 888-501-7195 to confirm that you have read and understand the information. Customers with questions can contact David Hedfors via email: david.hedfors@raysearchlabs.com
RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy.
Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are used. The ROI contraction tool uses six distances as input: right/left, inferior/superior and posterior/anterior. These contraction distances are, in error, pairwise reversed, i.e. right is interpreted as left, inferior is interpreted as superior, and posterior is interpreted as anterior.
On May 27, 2015 RaySearch Laboratories distributed Medical Device Correction notices to their customers via courier service. Within the Medical Device Correction notice, RaySearch Laboratories included a workaround to the problem for their customers. Customers should not use structure templates containing derived ROI definitions with non-uniform contractions. They should avoid using non-uniform contractions. In the case non-uniform contractions must be used, enter switched distances manually and review the result carefully before using it for treatment planning. Lastly, do not use humerus shielding in Automatic Breast Planning. Customers are also expected to complete and return the lower portion of the correction notice via fax to 888-501-7195. **CAPA** Correct the software problem in patch version 4.7.2 of RayStation 4.7, scheduled for market release June 2015.
RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is a software system designed for treatment planning and analysis of radiation therapy.
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. The magnitude of the error depends on the beam model output factor corrections and on the individual DMLC plan characteristics.
The firm, Raysearch Laboratories, sent a "Medical Device Correction/Field Safety Notice" and Reply Form(dated 3/3/2015) on 3/4/2015 via e-mail to the affected customers. The notice describes the product, problem and actions to be taken. The customers were instructed to deprecate any beam models that have been commissioned as DMLC capable for the affected linac types; do not commission beam models as DMLC capable for the affected linac types; educate physics staff and all users; inspect your system and identify all affected units of RayStation, acknowledge this notice by email or complete and return the Reply Form via fax to Americas market, RaySearch Americas Inc., at 888 501 7195, email: freddie.cardel@raysearchlabs.com or Rest of the world, RaySearch Laboratories AB, to email support@raysearchlabs.com. If you have any questions, contact Quality and Regulatory Affairs Manager, at +46 722 366 110 or email david.hedfors@raysearchables.com.
RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.
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 representation of an ROI can be wrong. This affects all dose-volume properties for such ROIs, including DVH, dose statistics, clinical goals and constraints or objective functions. Furthermore, if material override ROIs are used, or if the external is not represented by contours, the bug can trigger an error in the 3D dose distribution.
On April 25, 2014, RaySearch emailed all consignees of the affected product a copy of the recall notice as well as the response forms. Back up notification methods include phone calls and site visits.
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.
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.
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.
RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment 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
RaySearch Laboratories AB became aware of an issue with the dose calculation for some imported VMAT plans where controls points are defined with wide gantry angle spacing.
RaySearch sent a Device Correction letter dated May 8, 2015 via e-mailed to their customers. The letter identified the affected product, problem, actions to be taken by users and contact information.
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.
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
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.
RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy.
Potential for dose errors due to software program errors.
RaySearch Laboratories sent an Field Safety Notice, Medical Device Correction letter dated February 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. ACTIONS TO BE TAKEN BY THE USER A workaround that eliminates the described error is to select the discard rotations option in the Image Registration Module before creating a rigid registration intended to be used for hybrid deformable registration. Another option is to use the ROI based deformable registration when applicable, as this functionality is not affected by the error. SOLUTION This issue will be resolved in a patch release of RayStation, scheduled for market release February 28, 2014. Release schedule is subject to regulatory approval for some markets. In the meantime, this field safety notice is being distributed to all customers. CONTACT INFORMATION For further information, please contact For the Americas: Customer Support, RaySearch Americas, at +1 877 778 3849 For Europe, Asia and rest of the world: RaySearch Laboratories AB, at +46 8 5450 6130 Thank you for your cooperation, and we apologize for any inconvenience
RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.
On February 6, 2014, RaySearch Laboratories distributed Urgent Medical Device Correction notices to their customers via email regarding the affected product. To determine if the version you are using is affected, bring up the About box in the RayStation application and check if the number reported is "4.0.2.9". If so, the notice applies to your version. Customers are advised to inform all planning staff and all users about the instructions listed on the notice. Customers are advised to inspect their system and identify all installed units with the referenced software version numbers listed on the notice. Corrective labeling is distributed to the customers in the form of the safety notification attached to this report and the software problem will be resolved in RayStation patch 4.0.3 scheduled for market release end of February 2014 and in all future releases. For further information and return of the reply form, please contact: Freddie Cardel, Director of Customer Support, RaySearch Americas, (877) 778-3849 or freddie.cardel@raysearchlabs.com.
RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment planning and analysis of radiation therapy.
Under some circumstances, imported CT, MR and PET images are offset from their true positions by one pixel in one or two directions. Users must be aware of this information to avoid incorrect dose calculations during treatment planning.
RaySearch Laboratories sent an Urgent Field Safety Notice, Medical Device Correction letter dated January 28, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to educate their planning staff and all users about the recommended workarounds contained in the letter. Customers were also asked to inspect their product and identify all installed units that were infected and then complete the attached Reply Form and e-mail or scan a copy of the completed form to the firm. Customers were instructed to pass along this information to all those who need to be aware of this Medical Device Correction Customers with questions were instructed to contact the RaySearch support email at support@raysearchlabs. For questions regarding this recall call +46 8 545 06130.
Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.
Medical Device Correction Letters dated 10/23/13 were e-mailed to the user accounts on 10/23/13.
RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.
RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0" software due to dose miscalculations for bolus/external/fixation support structures on CT-image.
RaySearch Laboratories sent a Field Safety Notice, Medical Device Correction letter dated February 14, 2014 to their customers via email. The letter identified the affected product, problem and actions to be taken by the user. Customers with questions may contact Freddie Cardel, Director of Customer Support at 1-877-778-3849 or via email at freddie.cardel@raysearchlabs.com.
Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years. 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 fu
The firm decided to recall when an issue was found with the dose calculation in RayStation 2.5, Raystation 2.5.1. The problem has not caused any patient mistreatment or other incidents. However, the user must be aware of this information to avoid incorrect dose calculations during treatment planning. The dose calculation is not correctly normalized in the unusual case of preventing the optimizatio
The firm, RaySearch Laboratories, sent an "Urgent Field Safety Notice, Medical Device Correction" letter dated May 9, 2012 to its customers. The letter describes the product, problem and actions to be taken. The letter informed the customers that the "workaround is to not use segment MU optimization" and that there "is in general no need to manually adjust the segment shapes to such an extent there is need for a separate optimization of the segment MU." Additionally, the customers were instructed -Do not uncheck the "Segment shapes" check box; educate planning staff and all users about this workaround; inspect your product and identify all installed units with the noted software version numbers; and complete and return the Reply Form via fax to: RaySearch Americas Inc. at 888-501-7195; email: freddie.cardel@raysearchlabs.com and/or email to: Raysearch Laboratories AB at niclas.borglund@raysearchlabs.com. For further information and return of the Reply Form contact For the Americas: Director of Customer Support, RaySearch Americas at +1877 778 3849 or freddie.cardel@raysearchlabs.com; and For Europe, Asia and rest of the world: Director of Service, RaySearch Laboratories AB at +46 8 5450 6130 or niclas.borglund@raysearchlabs.com.