Viewray, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1251-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

MRIdian Linac Radiation Therapy System, Model 20000.

Product Classification:

Class II

Date Initiated: March 18, 2019

Date Posted: May 8, 2019

Recall Number: Z-1251-2019

Event ID: 82612

Reason for Recall:

A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.

Status: Terminated

Product Quantity: 17 devices

Code Information:

Serial Numbers 101,107, 201, 202, 203, 204, 205, 206, 209, 211, 213, 214, 217, 221, 223, 225, 228.

Distribution Pattern:

Distribution was made to FL, IL, MI, MO, NY, and WI. There was no government/military distribution. Foreign distribution was made to Denmark, France, Germany, Netherlands, South Korea, Switzerland, Turkey, UAE,

Voluntary or Mandated:

Voluntary: Firm initiated