Recall Z-2206-2016 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation Therapy Treatment Planning System --- designed for treatment planning and analysis of radiation therapy, provides treatment unit set up parameters and estimates dose distributions.
| Date | Jul 1, 2016 |
| Status | Terminated |
| Reason | An issue was found with the evaluation of biological clinical goals in RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5. Biological clinical goals for an adapted plan based on another planning CT than the original planning CT will show incorrect values. -- To the best of the firm's knowledge, the issue has not caused any patient mistreatment or other incidents. However, the user must be aware of the following information to avoid incorrect plan evaluation during treatment planning. |
| Root cause | Under Investigation by firm |
| Action | RaySearch Laboratories AB sent Field Safety Notice/Medical Device Correction #11905 Letter (RSL-D-61-298, dated 7/1/2016) to end users via e-mail on 7/1/2016. The letter informs end users of the issue and provides actions to be taken by the users (work around). |
| Quantity | US: 170 units |
| Distribution | California, Connecticut, Delaware, Florida, Hawaii, Maine, Missouri, New York, Ohio, Texas and Washington |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160093 | RayStation RaySearch Laboratories AB (PUBL), Apr 8, 2016 |