Recall Z-1930-2019 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) . Intended Use: software system designed for treatment planning and analysis of radiation therapy
| Date | Nov 20, 2017 |
| Status | Terminated |
| Reason | When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong |
| Root cause | Software design |
| Action | RaySearch issued Field Safety Notice, Medical Device Correction #24138 via email on November 20th, 2017. The letter identifies the product, issue, health risk and action to take: Do not use a number of histories above 6 million for electron dose calculation. Inspect all commissioned electron beam models for any applicator calculated with greater than 6 million. Contact customer support if you have any further questions. Confirm you have read and understood this notice. This issue will be resolved in the next version of RayStation, scheduled for market release in December 2017. Educate plannin |
| Quantity | 744 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171536 | RayStation RaySearch Laboratories AB (PUBL), Jun 27, 2017 |