FDA recall Z-1251-2019

Product

MRIdian Linac Radiation Therapy System, Model 20000.

Reason for recall

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

Distribution

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,

Key facts

Status

Terminated

Initiation date

2019-03-18

Report date

2019-05-08

Termination date

2022-06-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mountain View, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1251-2019