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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 RayStationsee related information
Date Initiated by FirmMarch 28, 2024
Date PostedMay 01, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1745-2024
Recall Event ID 94388
510(K)NumberK200569 
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
ProductRayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System.
Code Information UDI: 0735000201026620191220 and 0735000201029720200310; GTIN: 07350002010266 and 07350002010297; Serial Numbers: 9.1.0.933 and 9.2.0.483; Expiration Date: 2025-03-31.
Recalling Firm/
Manufacturer		 RAYSEARCH LABORATORIES AB
Eugeniavagen 18c
Stockholm Sweden
For Additional Information ContactOlympiada Lachana
+46-85-1053000
Manufacturer Reason
for Recall		Potential for reported SSD to be too high.
FDA Determined
Cause 2		Software design
ActionA Field Safety Notice for Medical Device Correction #133261, dated 3/28/24, was sent to consignees via email. Consignees were provided the instructions to use the Measure Tool to measure the distance in the patient view to make sure the reported SSD value is correct if it is to be used for patient setup or other critical tasks. If the SSD value is found to be incorrect, small changes to the isocenter, beam angles or the affected ROI's geometry can be made until the correct value is achieved. Consignees are to inform planning staff and all users of the workarounds provided in the Field Safety Notice. Consignees are to inspect their product and identify if installed units possess the affected software versions. Consignees are to reply to the recall notification confirming that they read and understood the Field Safety Notificaiton. RaySearch is to deploy a new version of RayStation/RayPlan to correct the issue, to be released in April 2024. The provided Field Safety Notice is to be maintained with affected units. Consignees with any questions are to contact quality@raysearchlabs.com.
Quantity in Commerce11 units
DistributionWorldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK.
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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