Elekta Unity systems recallZ-1297-2019 · Elekta Limited · initiated Apr 3, 2019
Class II Terminated All recalls posted in May 2019
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Elekta Limited or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling design
What the company is doing
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.
Recall details
- Recall number
- Z-1297-2019
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 3, 2019
- Posted by the FDA
- May 8, 2019
- Recalling firm
- Elekta Limited
- Quantity
- 9 devices
- Product code
- IYE
- FDA submissions
- K182076
- Distribution
- Worldwide Distribution - US Nationwide in the states of Texas and Wisconsin. Distribution internationally to Denmark, England, Germany, Italy, Netherlands
Product description
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.
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
1 device cleared under K182076 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Elekta Unity 1536549Elekta Limited · Accelerator, linear, medical1 recall6 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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