Recall Z-0380-2018 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayStation Product Usage: 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 used to administer treatments after review and approval by the intended user.
| Date | Jul 17, 2017 |
| Status | Terminated |
| Reason | For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in the QA module may be computed for a different setup than what is used for QA measurements. This could result in an incorrect dosage being provided to a patient. |
| Root cause | Device Design |
| Action | Ray Search sent a Field Safety Notice letter dated July 14, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter included a response form with instructions for workarounds until the software is corrected. |
| Quantity | 117 units |
| Distribution | US Nationwide Distribution - FL, WA, AZ, TN, MD, TX, FL, MI, Washington D.C. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171536 | RayStation RaySearch Laboratories AB (PUBL), Jun 27, 2017 |