Z-1675-2023Class II

Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil

Name: Z-1675-2023 Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil
Creator: Elekta, Inc.
Published: 2023-04-06
License: https://open.fda.gov/license/

Elekta Limited / initiated 2023-04-06 / Open, Classified / root cause: manufacturing process

FDA source

Elekta, Inc. began a recall of Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil on 2023-04-06. FDA classified it as Class II and gives the reason as "There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1675-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-06
Posted: 2023-06-02
Recalling firm: Elekta Limited
Product: Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 18 devices
Distribution: US Nationwide distribution in the states of FL, IA, NJ, NY, OK, PA, TN, WI, MI, LA, KS, NM and TX.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1675-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1675-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-14	2023-06-02

Product code IYE

K212114Class IIElekta UnityElekta Solutions AB / cleared 2021-10-01

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)