Elekta, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2289-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 30, 2020

Date Posted: June 17, 2020

Recall Number: Z-2289-2020

Event ID: 85651

Reason for Recall:

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

Status: Terminated

Product Quantity: 32 units

Code Information:

Serial numbers 600001 - 600043

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated