Z-1109-2019Class II

Elekta Unity, Image-Guided Radiation Therapy System

Name: Z-1109-2019 Elekta Unity, Image-Guided Radiation Therapy System
Creator: Elekta Limited
Published: 2019-03-12
License: https://open.fda.gov/license/

Elekta Limited / initiated 2019-03-12 / Terminated / root cause: software

FDA source

Elekta Limited began a recall of Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments... on 2019-03-12. FDA classified it as Class II and gives the reason as "Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acquired using these protocols do not represent the average position of the anatomy during the respiratory motion...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1109-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-12
Posted: 2019-04-08
Terminated: 2023-11-03
Recalling firm: Elekta Limited
Product: Elekta Unity, Image-Guided Radiation Therapy System 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: Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acquired using these protocols do not represent the average position of the anatomy during the respiratory motion cycle. The images are based on data acquired around full expiration. 2) The display of the images in the Elekta Unity Application software does not provide information about the protocol used to acquire the image eg. with or without respiratory triggering. Users must select an appropriate scan protocol that is representative of the respiratory phase used in the reference plan.
Root cause tag: software
FDA root cause: Software design
Action: The firm issued a field safety notice on 03/12/2019 by email. The notice explained the issue and cautioned the consignee to select an appropriate scan protocol that is representative of the respiratory phase used in the reference plan.
Quantity in commerce: 12 units
Distribution: Worldwide Distribution - US Nationwide in the states of TX, NY, WI, and Denmark, Germany, Italy, Netherlands, Sweden, United Kingdom
Product codes and lots: Unity Systems: 13553-006/600003, 13371-002/600021, 10817-011/600010, 10562-011/600016, 10719-T03001/600013, 30004070-001/600023, 10420-AVL-U/600008, 11014-UMCU-U/600007, 10157-006/600014, 11611-40/600011, 30001461-J001/600002, 11489-21/600009,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1109-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1109-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-17	2019-04-08

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)