Viewray, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1836-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated, in conjunction with the ViewRay System, an MRI image-guided radiation therapy system.

Product Classification:

Class II

Date Initiated: May 4, 2021

Date Posted: June 16, 2021

Recall Number: Z-1836-2021

Event ID: 87865

Reason for Recall:

Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.

Status: Terminated

Product Quantity: 8 versions

Code Information:

French version of the TDS software affected serial numbers: 214, 215, 226 and 240 German or Italian versions of the TDS software affected serial numbers: 203, 232, 108 and 244

Distribution Pattern:

International distribution only to the countries of France, Germany, Italy, and Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated