Recall Z-0679-2019 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, RayStation 7 and RayStation 8A
| Date | Nov 12, 2018 |
| Status | Terminated |
| Reason | Isocenter shifts when using dose tracking in RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A. In these versions, isocenter shifts in dose tracking are incorrectly interpreted according to the DICOM patient coordinate system. |
| Root cause | Under Investigation by firm |
| Action | RayStation issued Field Safety Notice, Medical Device Correction #37483, on 11/12/18 via email, states issue, action to be taken and correction of software in Dec 2018. |
| Quantity | 69 |
| Distribution | AZ CA CO CT DE FL GA HI ID IL LA MA MD ME MI MO MS NC NJ NY OH OR PA RI TN TX VA VT WA WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180379 | RayStation 7 RaySearch Laboratories AB (PUBL), Apr 25, 2018 |