FDA-Device2020-05-06Class II

ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software

Viewray, Inc.

Hazard

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. When this occurs in the treatment planning workflow, the registration fails to align the dose with the image and the user is unable to proceed.

Sold states

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 them and they forwarded them to the sites.

Affected count

Manufactured in

815 E Middlefield Rd, N/A, Mountain View, CA, United States

Products

ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1803-2020

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief