ViewRay (NSDQ:VRAY) has issued a field safety notice for its MRIdian System Treatment Planning and Delivery System software.
The urgent device correction stems from some cases where a dose that was previously administered to a patient may not be accurately registered with the daily scan. There have been no reports of patients affected by the issue.
When a user registers dose and structures in the treatment delivery workflow, the system could show an alignment discrepancy between the previously delivered dose and the displayed patient anatomy and structures. The company says the impact may not be obvious to the user depending on the magnitude of the misalignment. As a result, the previously delivered dose would be incorrectly accounted for and could result in a higher or lower dose than calculated for the treatment plan.
ViewRay recommends not proceeding with plan summation if the treatment planning workflow fails to align the dose with the image. The company also recommends contacting ViewRay customer support for assistance when summing plans in the planning workflow.
The company is currently working on a resolution for the issue and customers will be contacted by customer support when a resolution is available.