Z-2289-2020Class II

Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system -

Name: Z-2289-2020 Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system -
Creator: Elekta, Inc.
Published: 2020-04-30
License: https://open.fda.gov/license/

Elekta Limited / initiated 2020-04-30 / Terminated / root cause: packaging

FDA source

Elekta, Inc. began a recall of Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation therapy treatments and stereotactic... on 2020-04-30. FDA classified it as Class II and gives the reason as "potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2289-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-30
Posted: 2020-06-05
Terminated: 2021-08-04
Recalling firm: Elekta Limited
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.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray.
Root cause tag: packaging
FDA 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 in commerce: 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.
Product codes and lots: Serial numbers 600001 - 600043

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2289-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2289-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-05

Product code IYE

K192482Class IIElekta UnityElekta Limited / cleared 2019-12-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)