Recall Z-1251-2019 ยท IYE Accelerator, Linear, Medical
Viewray, Inc.
MRIdian Linac Radiation Therapy System, Model 20000.
| Date | Mar 18, 2019 |
| Status | Terminated |
| Reason | A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur. |
| Root cause | Software design |
| Action | An undated letter was issued via email to customers on 3/18/2019, except for one customer who was issued the letter on 3/26/2019. |
| Quantity | 17 devices |
| Distribution | Distribution was made to FL, IL, MI, MO, NY, and WI. There was no government/military distribution. Foreign distribution was made to Denmark, France, Germany, Netherlands, South Korea, Switzerland, Turkey, UAE, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170751 | MRIdian Linac System with 138-leaf Collimator Viewray, Incorporated, Jun 7, 2017 |