Recall Z-1598-2021 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs
| Date | Apr 7, 2021 |
| Status | Terminated |
| Reason | When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as selected in the Treatment course list in Dose tracking and the fractions that are included in the dose summation. The issue only affects RayTreat users and only the Total dose option. Accumulation and other options in Dose tracking are correct. |
| Root cause | Software design |
| Action | On 04/08/2021, Gore issued an Urgent Medical Device Removal notice to customer via letter notifying them that a Gore Viabil Biliary Endoprosthesis 10 mm x 10 cm device appeared shorter than the labeled length. |
| Distribution | Domestic: TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200569 | RayStation RaySearch Laboratories AB (PUBL), Sep 24, 2020 |