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Class 2 Device Recall RayStation/RayPlan |
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Date Initiated by Firm |
November 18, 2019 |
Create Date |
December 23, 2019 |
Recall Status1 |
Terminated 3 on November 10, 2020 |
Recall Number |
Z-0736-2020 |
Recall Event ID |
84508 |
510(K)Number |
K190387
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Product Classification |
System, planning, radiation therapy treatment - Product Code MUJ
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Product |
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, 7.0, 8.0, 8.1, 9.0 - 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 |
Software Version Numbers: 4.0.0.14 , 4.0.1.4 , 4.0.2.9 , 4.0.3.4 , 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 , 6.3.0.6 , 7.0.0.19 , 8.0.0.61 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , or 9.0.0.113 |
Recalling Firm/ Manufacturer |
RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden
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Manufacturer Reason for Recall |
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 invalidated and needs to be recalculated before the plan can be approved or exported.
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FDA Determined Cause 2 |
Software design |
Action |
Field Safety Notice, Medical Device Correction notification letters dated 11/18/19 were sent to customers.
ACTIONS TO BE TAKEN BY THE USER
" Be aware that the MU of static arc beams may change unexpectedly when using the Edit beam dialog or when editing the beam aperture.
" Always review the final dose before approving a plan for treatment:
WARNING!
Plan review and approval. All treatment plan data shall be carefully reviewed and
approved by a qualified person before it is used for radiotherapy treatment purposes.
A plan (beam set) that is 'optimal' with respect to the optimization goals may still be inappropriate for clinical use. (508826, 508814)
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 that you have read and understood this notice by replying to the notification email.
SOLUTION
This issue will be resolved in the next version of RayStation/RayPlan, scheduled for market release in December 2019 (subject to market clearance in some markets). If customers wish to continue using versions of RayStation/RayPlan affected by this notice, all users must maintain awareness of this notice.
Alternatively, customers can choose to upgrade to the new version once it becomes available for clinical use.
TRANSMISSION OF THIS 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 any version of RayStation/RayPlan affected by this issue is in use to ensure effectiveness of the workaround. |
Quantity in Commerce |
956 Devices/Licences |
Distribution |
US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, VT, WA, and WI. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = MUJ and Original Applicant = RaySearch Laboratories AB (publ)
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