—#181464

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.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K192482
Affected lot / code info: Serial numbers 600001 - 600043

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

The firm notified the service engineers of the issue and the risk to health (exposure to legionella) by email on 04/30/2020. The firm followed with a letter disseminated on 05/12/2020 to customers and service engineers which discussed the hazard and Elekta's updated preventative maintenance.

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter NE, Ste 50, Atlanta, Georgia 30346-1227

Distribution

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.

Timeline

Recall initiated: 2020-04-30
Posted by FDA: 2020-06-05
Terminated: 2021-08-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181464. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.