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U.S. Department of Health and Human Services

Class 2 Device Recall RayStation

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  Class 2 Device Recall RayStation see related information
Date Initiated by Firm March 25, 2021
Create Date April 15, 2021
Recall Status1 Open3, Classified
Recall Number Z-1427-2021
Recall Event ID 87666
510(K)Number K200569  
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
Product RayStation Model Number: (9A), 9B (, 9B Service pack (, 10A (, 10A Service pack (, 10B (

Code Information Software version: 9A, 9B, 10A, 10B
Recalling Firm/
Sveavagen 9
Stockholm Sweden
Manufacturer Reason
for Recall
Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.
FDA Determined
Cause 2
Under Investigation by firm
Action On 03/25/2021, RaySearch Laboratories issued an Urgent Medical Device Correction notice via email to their customer notifying them of an issue found with the display of flags in RayTreat. Flags edited in RayCare after a patient has been checked in, may not be updated in RayTreat.
Quantity in Commerce 1 system
Distribution US Nationwide in the state of TN.
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)