Recall Z-0676-2020 ยท IYE Accelerator, Linear, Medical
Viewray, Inc.
MRIdian Linac Radiation Therapy System Model 10000 and 20000
| Date | Dec 12, 2019 (initiated Mar 3, 2019) |
| Status | Terminated |
| Reason | Issue with transferring treatment regiment from one system to another. Adequate instructions for transferring treatment plan(s) are not provided within the operator's manual or within the software operating system. |
| Root cause | Error in labeling |
| Action | On 03/03/2019, the firm emailed an "URGENT DEVICE RECALL" to customers to inform them of a safety issue with the Treatment Planning and Delivery System (TPDS) in the MRIdian System. The notice explained that when a partially-completed patient treatment regiment is moved to their system from another system, the use needs to rescale the plan. The TPDS does not automatically rescale the treatment plan. The customers are instructed: If they want to move a treatment plan from one system to another and still show the total original prescribed dose on the MRIdian TPDS the customer will have multip |
| Quantity | 24 Systems |
| Distribution | US - CA, FL, IL, MI, MO, NY, and WI OUS: Denmark, France, Germany, Italy, Japan, Netherlands, Turkey, South Korea, and UAE |
| FDA record | Open on fda.gov |