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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 RayCaresee related information
Date Initiated by FirmMarch 03, 2021
Create DateMarch 19, 2021
Recall Status1 Open3, Classified
Recall NumberZ-1281-2021
Recall Event ID 87471
510(K)NumberK200487 
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
ProductRayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.
Code Information S/N: 3.1.0.60341 Software: RayCare 3B (3.1.0.60341) UDI: 0735000201028020191220; 
Recalling Firm/
Manufacturer		 RAYSEARCH LABORATORIES AB
Sveavagen 9
Stockholm Sweden
Manufacturer Reason
for Recall		Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later
FDA Determined
Cause 2		Software design
ActionRaysearch issued via E-mail on 03 March 2021, Field Safety Notice, Medical Device Correction #75198 letter stating reason for recall, health risk and action to take: RaySearch will check if the issue affects your system and apply the below solution. " Until the solution has been applied, be aware that the message body is missing from messages created in RayCare 2. " Confirm you have read and understood this notice by replying to the notification email. For regulatory information, please contact quality@raysearchlabs.com SOLUTION This issue will be resolved by RaySearch staff using a support tool. Using the support tool, the message body will be restored to all messages in the currently used RayCare version.
Quantity in Commerce1 unit
DistributionUS Nationwide distribution in the state of TN.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MUJ
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