Recall Z-1803-2020 ยท IYE Accelerator, Linear, Medical
Viewray, Inc.
ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software
| Date | Nov 18, 2019 |
| Status | Terminated |
| Reason | Registering dose and structures in the treatment delivery workflow could result in an alignment discrepancy between the imported previously delivered dose and the displayed patient anatomy and structures. The MRIdian TPDS software shows this misalignment to the user in the predicted dose-volume histogram (DVH). The misalignment impact may not be obvious to the user. During plan re-optimization the previously delivered dose would be incorrectly accounted for by the software. This may result in unexpectedly higher or lower dose than the intended dose calculated for the subsequent treatment plan |
| Root cause | Software design |
| Action | On 11/18/2019, the firm send an "Urgent Device Correction" letter to customers via email to inform them firm has become aware of an issue impacting the MRIdian System Treatment Planning and Delivery System (TPDS) software. The issue relates to an optional feature related to using previously delivered dose to make a new plan on MRIdian. The firm determined that in some cases dose previously delivered to a patient may not be accurately registered with a daily scan. The firm is instructing its customers to: 1) Do not: Sum previously delivered treatment plans in the treatment delivery workflow |
| Quantity | 32 |
| Distribution | Worldwide distribution. US states of MO, WI, CA, FL, MI, NY, MI, IL, and MA. South Korea, Netherlands, Italy, Japan, Germany, UAE, Turkey, France, Israel, Denmark, Switzerland, and United Kingdom. The distributors are assigned to applicable regions. Firm send the Urgent Device Corrections to t |
| FDA record | Open on fda.gov |