Z-2473-2020Class II

Elekta Unity, Image-Guided Radiation Therapy System

Name: Z-2473-2020 Elekta Unity, Image-Guided Radiation Therapy System
Creator: Elekta, Inc.
Published: 2019-12-18
License: https://open.fda.gov/license/

Elekta Limited / initiated 2019-12-18 / Terminated / root cause: manufacturing process

FDA source

Elekta, Inc. began a recall of Elekta Unity, Image-Guided Radiation Therapy System on 2019-12-18. FDA classified it as Class II and gives the reason as "There have been reports of excessive heating in the MRL Gradient Connection Module". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2473-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-18
Posted: 2020-06-30
Terminated: 2021-06-15
Recalling firm: Elekta Limited
Product: Elekta Unity, Image-Guided Radiation Therapy System
Product code: IYE Accelerator, Linear, Medical
Reason for recall: There have been reports of excessive heating in the MRL Gradient Connection Module.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Initially, the firm issued an email on 12/18/2019 to their field engineers which said they had attached a "Knowledge Article" which provided instructions on how to inspect the Philips Marlin 1.5T system used in the Elekta Unity MR Linac. On 5/11/2020, the firm issued an Urgent Important Field Safety Notification dated May, 2020, via email to consignees which explained the problem, clinical impact, and said that initial corrective actions have been performed on all impacted sites to ensure the gradient coil connection assembly is correct. It goes onto say that extensive testing of the incorrect connection material has been completed to ensure that continued use of the Elekta Unity system is acceptable, however, it remained that further actions can be taken to reduce the risk.
Quantity in commerce: 21 devices
Distribution: Distributed in US - PA, NY, and IA. Distributed ROW - Australia, Canada, China, Switzerland, Denmark, Hong Kong, Italy, Netherlands, Sweden, Thailand, Turkey, UK. There was no government/military distribution.
Product codes and lots: Elekta Unity Serial numbers 600014, 600016, 600017, 600018, 600019, 600020, 600021, 600022, 600023, 600024, 600025, 600026, 600027, 600028, 600029, 600030, 600031, 600032, 600033, 600034, 600035

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2473-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2473-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-30

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)