FDAFDA · Food and drugs·Recall number Z-2289-2020
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.
Published June 17, 2020 · Recall initiated: April 30, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Elekta, Inc.
- Distributor
- 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.
- Lot
- Serial numbers 600001 - 600043
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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