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Class 2 Device Recall RayStation software system |
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| Date Initiated by Firm |
December 19, 2019 |
| Date Posted |
January 27, 2020 |
| Recall Status1 |
Terminated 3 on November 24, 2020 |
| Recall Number |
Z-0866-2020 |
| Recall Event ID |
84705 |
| 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. Models 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0.
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| Code Information |
Software Versions Numbers: 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 , 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 , 9.0.0.113 . |
Recalling Firm/
Manufacturer |
RAYSEARCH LABORATORIES AB
Sveavagen 9
Stockholm Sweden
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Manufacturer Reason
for Recall |
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 leaf behavior. There is an interoperability issue with Elekta regarding setting of guard leaves. iii)SSD, when intended as source-to-surface distance, it sometimes gives source-to-skin distance.To the best of our knowledge, these issues have not caused any patient mistreatment or other incidents. However, the user must be aware of the following information to avoid incorrect dose calculations during treatment planning.
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FDA Determined
Cause 2 |
Software design |
| Action |
Field Safety Notice, Medical Device Correction #52889 #52672
#52971 dated 12/18/2019. ACTIONS TO BE TAKEN BY THE USER
" i. Do not use the options Map ROI(s) or Map ROI(s) reversed, only available by right-clicking in the ROI list. Instead, use the Copy ROI geometries dialog available in the Structure Definition module or the Map ROIs dialog available in the Deformable Registration module.
" ii. Be aware that the Elekta guard leaf setting from RayStation may be overridden by the R&V system or TCS. Contact the suppliers of your R&V system and TCS for more information. Scripting can be used to position the guard leaves according to the settings of the delivery system to avoid the overrides.
" iii. Do not use the beam.GetSSD() scripting method. If needed in scripting, see RayCommunity.
" iv. Do not use the SSD value displayed in the DRR in the plan report or exported DRR. Instead, use the SSD value displayed in the Beam data section of the plan report. Please educate planning staff and all users about these workarounds.
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 email.
SOLUTION
i. The Map ROI issue will be resolved in a future version of RayStation, scheduled for market release in May 2020 (subject to market clearance in some markets).
ii. The Elekta guard leaves issue will be resolved in a future version of RayStation, scheduled for market release in May 2020 (subject to market clearance in some markets).
iii. The SSD issue will be resolved in the next version of RayStation, scheduled for market release in December 2019 (subject to market clearance in some markets).
If customers wish to continue using versions of RayStation 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.
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| Quantity in Commerce |
3114 Devices/Licenses |
| Distribution |
US Nationwide distribution in 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, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, VT, WA, 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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