FDA recall Z-0676-2020

Product

MRIdian Linac Radiation Therapy System Model 10000 and 20000

Reason for recall

Issue with transferring treatment regiment from one system to another. Adequate instructions for transferring treatment plan(s) are not provided within the operator's manual or within the software operating system.

Distribution

US - CA, FL, IL, MI, MO, NY, and WI OUS: Denmark, France, Germany, Italy, Japan, Netherlands, Turkey, South Korea, and UAE

Key facts

Status

Terminated

Initiation date

2019-03-03

Report date

2019-12-18

Termination date

2021-04-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mountain View, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0676-2020