RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.
Recall
- Recall Number
- Z-1747-2024
- Event Number
- 94388
- Firm
- RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden
- FEI Number
- 3007774465
- Product Code
- MUJ
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- March 28, 2024
- Posted
- May 1, 2024
Description
RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
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 [email protected].
Worldwide 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.
18 units