Recall Z-0736-2020 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0 - Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be
| Date | Nov 18, 2019 |
| Status | Terminated |
| Reason | Editing a static arc beam may unexpectedly set the MU of the beam to its initial default value of 200 MU. If the bug is triggered, the dose is invalidated and needs to be recalculated before the plan can be approved or exported. |
| Root cause | Software design |
| Action | Field Safety Notice, Medical Device Correction notification letters dated 11/18/19 were sent to customers. ACTIONS TO BE TAKEN BY THE USER " Be aware that the MU of static arc beams may change unexpectedly when using the Edit beam dialog or when editing the beam aperture. " Always review the final dose before approving a plan for treatment: WARNING! Plan review and approval. All treatment plan data shall be carefully reviewed and approved by a qualified person before it is used for radiotherapy treatment purposes. A plan (beam set) that is 'optimal' with respect to the optimization goals may |
| Quantity | 956 Devices/Licences |
| Distribution | US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, VT, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190387 | RayStation RaySearch Laboratories AB (PUBL), Jun 19, 2019 |