Elekta Unity recallZ-1675-2023 · Elekta, Inc. · initiated Apr 6, 2023
Open, Classified
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, Inc. 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 a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.
FDA root cause category: Process design
What the company is doing
The recalling firm issued the Field Safety Notice dated March 2023 via email on 4/6/2023 describing the problem, the clinical impact, and the recommended user action, which is that no actions are required to be taken by the user. The Unity system is safe for clinical use without restriction. The consignee is informed the letter is to notify them there will be action taken on the Elekta Unity system to further reduce the potential risk of overheating within the MR Gradient Coil which could lead to system downtime. The letter is to be posted in a place accessible to all users and appropriate personnel are to be advised on the content of the letter. The letter contains Elekta Corrective Actions, which says the update will be provided via Elekta's Field Change Order process once available and that their local Elekta service representative will contact the consignee to arrange for this activity to be completed. An acknowledgement Form was enclosed to be returned to Elekta immediately upon receipt but no later than within 30 days. The device serial number and location or site of the device is to be reported and the consignee is to sign it to acknowledge they have read and understand the notice and accept the implementation of any given recommendation. UPDATED 12-JUN-23 An updated Important Field Safety Notification was released to customers by email in which supersedes the previous Notice under ref: 200-01-801-012 released on 06-APR-23. The new FSN includes additional information under Recommended User Action.
Recall details
- Recall number
- Z-1675-2023
- Status
- Open, Classified
- Initiated by the company
- Apr 6, 2023
- Posted by the FDA
- Jun 2, 2023
- Recalling firm
- Elekta, Inc.
- Quantity
- 18 devices
- Product code
- IYE
- FDA submissions
- K212114
- Distribution
- US Nationwide distribution in the states of FL, IA, NJ, NY, OK, PA, TN, WI, MI, LA, KS, NM and TX.
Product description
Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
Code information (models, lots, serial numbers)
UDI GTIN 05060191071598, serial numbers: 14117-007/600034, 10632-010/600036, 10817-011/600010, 10905-008/600037, 11198-010/600047, 11198-011/600048, 11830-010/600064, 11888-004/600072, 12108-007/600019, 13371-002/600021, 13553-006/600003, 30003193-003/600074, 13120-017/600073, 11328-019/600059, 14232-001/600095, 12269-004/600100, 11008-003/600104, 13212-007/600106
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Elekta Unity 1553106Elekta Limited · Accelerator, linear, medical1 recall1 report
Product lines
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 16, 2026. Text above is shown as published by the FDA.
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