RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System.
Brand
RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden
Lot Codes / Batch Numbers
UDI: 0735000201038920210518, 0735000201043320210610, 0735000201044020210916 and 0735000201063120220616, GTIN: 07350002010389, 07350002010433, 07350002010440 and 07350002010631, Serial Numbers: 11.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15, Expiration Date: 2027-06-22.
Products Sold
UDI: 0735000201038920210518, 0735000201043320210610, 0735000201044020210916 and 0735000201063120220616; GTIN: 07350002010389, 07350002010433, 07350002010440 and 07350002010631; Serial Numbers: 11.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15; Expiration Date: 2027-06-22.
RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden is recalling RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning Syst due to Potential for reported SSD to be too high.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for reported SSD to be too high.
Recommended Action
Per FDA guidance
A 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026