Viewray Incorporated: Medical Device Recall in 2016 - (Recall #: Z-1309-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian¿ System) is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated

Product Classification:

Class II

Date Initiated: March 7, 2016

Date Posted: April 6, 2016

Recall Number: Z-1309-2016

Event ID: 73550

Reason for Recall:

When editing the isocenter or the couch position of the plan while in the treatment workflow (in the Points screen) and re-optimizing, the software will not prompt the user to shift the couch to the new isocenter. As a result there is the potential to deliver dose to the initial isocenter rather than the new location.

Status: Terminated

Product Quantity: 5 units

Code Information:

Model number: 10000 Catalog/Part Number: 10000 Serial Numbers: 100, 101, 102, 104 & 105

Distribution Pattern:

Worldwide Distribution - US including CA, FL, MO & WI., and International distribution to the Republic of Korea and The Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated