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Class 2 Device Recall RayStation |
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Date Initiated by Firm |
April 07, 2021 |
Create Date |
May 14, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1598-2021 |
Recall Event ID |
87868 |
510(K)Number |
K200569
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Product Classification |
System, planning, radiation therapy treatment - Product Code MUJ
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Product |
RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs |
Code Information |
Software version number: 8.0.0.6 , 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 |
Recalling Firm/ Manufacturer |
RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden
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Manufacturer Reason for Recall |
When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as selected in the Treatment course list in Dose tracking and the fractions that are included in the dose summation. The issue only affects RayTreat users and only the Total dose option. Accumulation and other options
in Dose tracking are correct.
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FDA Determined Cause 2 |
Software design |
Action |
On 04/08/2021, Gore issued an Urgent Medical Device Removal notice to customer via letter notifying them that a Gore Viabil Biliary Endoprosthesis 10 mm x 10 cm device appeared shorter than the labeled length. |
Distribution |
Domestic: TN |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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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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