Recall Z-1743-2024 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System.
| Date | May 1, 2024 (initiated Mar 28, 2024) |
| Status | Open, Classified |
| Reason | Potential for reported SSD to be too high. |
| Root cause | Software design |
| Action | 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 N |
| Quantity | 5 units |
| Distribution | 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 Zeal |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190387 | RayStation RaySearch Laboratories AB (PUBL), Jun 19, 2019 |