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U.S. Department of Health and Human Services

Class 2 Device Recall RayStation SP2

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  Class 2 Device Recall RayStation SP2 see related information
Date Initiated by Firm May 18, 2020
Create Date June 10, 2020
Recall Status1 Terminated 3 on August 06, 2021
Recall Number Z-2342-2020
Recall Event ID 85723
510(K)Number K190387  
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
Product RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Code Information UDI # 07350002010075  Build number:  6.2.0.7
Recalling Firm/
Manufacturer		 RAYSEARCH LABORATORIES AB
Sveavagen 9
Stockholm Sweden
Manufacturer Reason
for Recall		 Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
FDA Determined
Cause 2		 Software design
Action On May 18, 2020, RaySearch Laboratories emailed an Urgent Field Safety Notice, Medical Device Correction #60564 letter to their customers. The letter listed the following actions to be taken by the users: always use the MC dose engine for final dose calculation, in robustness analysis, and dose tracking if possible (the MC dose engine is available in versions RayStation 6.0 and later); if the pencil beam dose engine is used for final dose calculation, ensure that all spots intersect the External ROI as seen in the Beams Eye View (BEV) of the Plan optimization module; if they do not, expand the External ROI so that all spots do intersect the External ROI, and re-optimize the plan if necessary; if the MC dose engine is used for final dose calculation, and hot spots related to tangential fields are observed, expand the External ROI so that the central axis of all spots intersect the External ROI and re-optimize the plan; educate planning staff and all users about this workaround; inspect your product and identify all installed units with the above software version number(s). RaySearch Laboratories asked all customers to confirm that they have read and understood the notice by replying to the notification email.
Distribution US Nationwide distribution including in the states of Florida, Georgia, Utah, Virginia, California, Maryland, Arizona, Texas, Washington DC, Missouri, Massachusetts, Illinois, Oklahoma, New Jersey, Tennessee, and Louisiana.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = RaySearch Laboratories AB (publ)
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