Elekta, Inc. recalls Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation ther

Recalled June 17, 2020 · FDA recall Z-2289-2020 · Elekta

Hazard

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

Units

32 units

Sold at

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.

Description

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

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.

Manufacturer(s)

Elekta, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →