Z-1297-2019Class II

Elekta Unity systems

Name: Z-1297-2019 Elekta Unity systems
Creator: Elekta Limited
Published: 2019-04-03
License: https://open.fda.gov/license/

Elekta Limited / initiated 2019-04-03 / Terminated / root cause: labeling and UDI

FDA source

Elekta Limited began a recall of Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation... on 2019-04-03. FDA classified it as Class II and gives the reason as "There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast agents for imaging or image guidance purposes has not been validated". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1297-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-03
Posted: 2019-05-08
Terminated: 2023-05-01
Recalling firm: Elekta Limited
Product: Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging 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. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast agents for imaging or image guidance purposes has not been validated.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Elekta notified customers on about 04/03/2019 via email with "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" letter. Instructions included to ensure all staff working with Elekta Unity are aware of the issue and recall information and post the recall notice in a place accessible to all users, e.g. Instructions for use, until the recall is closed. Additionally customer were asked to complete and return the Acknowledgement Form.
Quantity in commerce: 9 devices
Distribution: Worldwide Distribution - US Nationwide in the states of Texas and Wisconsin. Distribution internationally to Denmark, England, Germany, Italy, Netherlands
Product codes and lots: Product Code: UNITY SYSTEM/13553-006/600003, UNITY SYSTEM/10817-011/600010, UNITY SYSTEM/10562-011/600016; UNITY SYSTEM/10719-T03001/600013, UNITY SYSTEM/30004070-001/600023, UNITY SYSTEM/10420-AVL-U/600008, UNITY SYSTEM/11014-UMCU-U/600007, UNITY SYSTEM/11611-40/600011, UNITY SYSTEM/11489-21/600009; UDI: 1536549, 1536549

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1297-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1297-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-15	2019-05-08

Product code IYE

K182076Class IIElekta UnityElekta Limited / cleared 2018-12-04

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)