FDA recall Z-1836-2021

Product

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.

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2021-05-04

Report date

2021-06-16

Termination date

2023-10-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mountain View, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1836-2021