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U.S. Department of Health and Human Services

Class 2 Device Recall RaySearch

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  Class 2 Device Recall RaySearch see related information
Date Initiated by Firm September 22, 2021
Create Date March 31, 2022
Recall Status1 Open3, Classified
Recall Number Z-0849-2022
Recall Event ID 89800
510(K)Number K211867  
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
Product RayStation/RayPlan versions 4 - 11A, including service packs.
Build Stations: 4.0.0.14, 4.0.3.4, 4.3.0.14, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 4.9.0.42, 5.0.1.11, 5.0.2.35, 5.0.3.17, 6.0.0.24, 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, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 11.0.0.951 or 11.0.1.29
Code Information Product name (build number) UDI-DI RayStation 4.0 (4.0.0.14) to RayStation 5 Service Pack 2 (5.0.2.35) N/A RayStation 5 Service Pack 3 (5.0.3.17) 07350002010020 RayStation 6/RayPlan 2 (6.0.0.24) 07350002010013 RayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2) 07350002010082 RayStation 6/RayPlan 2 Service Pack 2 (6.2.0.7) 07350002010075 RayStation 6/RayPlan 2 Service Pack 3 (6.3.0.6) 07350002010242 RayStation/RayPlan 7 (7.0.0.19) 07350002010068 RayStation/RayPlan 8A (8.0.0.61) 07350002010112 RayStation/RayPlan 8A Service Pack 1 (8.0.1.10) 07350002010136 RayStation/RayPlan 8B (8.1.0.47) 07350002010129 RayStation/RayPlan 8B Service Pack 1 (8.1.1.8) 07350002010204 RayStation/RayPlan 8B Service Pack 2 (8.1.2.5) 07350002010235 RayStation/RayPlan 9A (9.0.0.113) 07350002010174 RayStation/RayPlan 9B (9.1.0.933) 07350002010266 RayStation/RayPlan 9B Service Pack 1 (9.2.0.483) 07350002010297 RayStation/RayPlan 10A (10.0.0.1154) 07350002010303 RayStation/RayPlan 10A Service Pack 1 (10.0.1.52) 07350002010365 RayStation/RayPlan 10B (10.1.0.613) 07350002010310 RayStation 11A (11.0.0.951) 07350002010389 RayStation 11A Service Pack 1 (11.0.1.29) 07350002010433
Recalling Firm/
Manufacturer		 RAYSEARCH LABORATORIES AB
Sveavagen 9
Stockholm Sweden
Manufacturer Reason
for Recall		 An issue where the combined density in a dose grid voxel partially covered by the External ROI and also partially covered by an ROI of type Bolus, Support or Fixation may be unexpected.The density in the voxel can be both under- and overestimated
FDA Determined
Cause 2		 Device Design
Action RaySearch issued Field Safety Notice, Medical Device Correction #84236 via E-mail on 22 September 2021. Letter states reason for recall, health risk and action to take: " Use the automatic tool in RayStation/RayPlan to create the External ROI. " When using a Support or Fixation ROI of tissue-like material (density around 1), extend this ROI a few millimeters inside the External ROI to cover the surface voxels of the patient. " If the Support or Fixation ROI differs significantly from the adjacent body tissue, an extra help ROI with material override set to a suitable material, for example, Skin, can be created inside the External ROI. The help ROI must have a width of a few millimeters and extend along the part of the patient surface connected to the Support or Fixation ROI. The same workflow can be used for Bolus ROIs in combination with electron beams. " If the bolus/support/fixation device is part of the CT data, an alternative solution is to include its structure inside the External ROI. In this case the structure should not be defined as a Bolus, Support or Fixation ROI, but as a normal ROI, by setting the ROI type to, for example Other . When included in the External ROI, the user can choose to use the CT densities or to apply a material override to the structure. If this method is applied for a bolus, the user must make sure that only the applicable beams pass through the structure. " For protons and light ions, the user should consider using a higher density uncertainty than normal in robust optimization for active scanning techniques and larger proximal and distal margins for the target in passive techniques, when shooting through a Fixation or Support ROI. " Educate planning staff and all users about this workaround. " Inspect your product and identify all installed units with the above software version number(s). " Confirm you have read and understood this notice by replying to the notification email. This issue will be resolved in the next version of
Quantity in Commerce 478 licenses US
Distribution US Nationwide.
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = RaySearch Laboratories AB (publ)
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