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U.S. Department of Health and Human Services

Class 2 Device Recall RayCare

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  Class 2 Device Recall RayCare see related information
Date Initiated by Firm July 29, 2020
Create Date August 27, 2020
Recall Status1 Open3, Classified
Recall Number Z-2899-2020
Recall Event ID 86249
510(K)Number K200487  
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
Product RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care.
Code Information Model #: 2C SP2, 2C SP3, 3A SP1, 3B and 4A Software Version: 2.2.2.30782 , 2.2.3.53423 , 3.0.1.43597 , 3.1.0.60341 , 4.0.0.60621"
Recalling Firm/
Manufacturer		 RAYSEARCH LABORATORIES AB
Sveavagen 9
Stockholm Sweden
Manufacturer Reason
for Recall		 When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image review task will guide you to the image viewer with the treatment image related to the fraction and the planning image selected. When starting the task, an error message might be displayed stating: Review files not available.
FDA Determined
Cause 2		 Under Investigation by firm
Action Only 1 effected consignee who was emailed a field safety notice on 08/05/2020. This letter instructs the user to: Be aware that registration of a treatment image with a corresponding study with multiple series in the same frame of reference might block the offline image review. Verify the correctness of the data in RayCare PACS before using the data for any decision making. -Please educate 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.
Distribution US Nationwide distribution including in the state of Tennessee.
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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