FDA Medical Device Recalls (openFDA)
Elekta, Inc.: 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.
- Recall number
- Z-2289-2020
- Recalling firm
- Elekta, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2020-04-30
- Posted
- 2020-06-05
- Terminated
- 2021-08-04
- Reason
- potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 32 units
- 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.
- Lot, serial or model codes
- Serial numbers 600001 - 600043
- 510(k) numbers
- ["K192482"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 1037831
- Firm city
- Atlanta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28