FDA recall Z-2289-2020

Elekta, Inc. · Class II · device

Product

Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan.

Reason for recall

potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray.

Distribution

Worldwide distribution - US Nationwide distribution including in the states of PA, WI, NY, TN, NJ, IA, TX, and the countries of Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Thailand, Turkey, UK.

Key facts

Status
Terminated
Initiation date
2020-04-30
Report date
2020-06-17
Termination date
2021-08-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Atlanta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2289-2020