FDA recall Z-2473-2020

Product

Elekta Unity, Image-Guided Radiation Therapy System

Reason for recall

There have been reports of excessive heating in the MRL Gradient Connection Module.

Distribution

Distributed in US - PA, NY, and IA. Distributed ROW - Australia, Canada, China, Switzerland, Denmark, Hong Kong, Italy, Netherlands, Sweden, Thailand, Turkey, UK. There was no government/military distribution.

Key facts

Status

Terminated

Initiation date

2019-12-18

Report date

2020-07-08

Termination date

2021-06-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Atlanta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2473-2020