Viewray, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1803-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 18, 2019

Date Posted: May 6, 2020

Recall Number: Z-1803-2020

Event ID: 85441

Reason for Recall:

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.

Status: Terminated

Product Quantity: 32

Code Information:

Model No.10000 - Serial No's:. 100,104,105,112,113 Model No. 20000 - Serial No's: 101,102,107,108,200,201,203,204,206,207,209,211, 213,214,215,216,217,218,221,223,225,227,228,232,238,240,243, 244,247,250

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated