Z-1164-2026Class II

Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity...

Name: Z-1164-2026 Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity...
Creator: Elekta, Inc.
Published: 2025-12-14
License: https://open.fda.gov/license/

Elekta Limited / initiated 2025-12-14 / Open, Classified / root cause: manufacturing process

FDA source

Elekta, Inc. began a recall of Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product... on 2025-12-14. FDA classified it as Class II and gives the reason as "Due to a manufacturing issue and electrical grounding of 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-1164-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-14
Posted: 2026-01-23
Recalling firm: Elekta Limited
Product: Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product Description: Digital Linear Accelerator Component: No
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Due to a manufacturing issue and electrical grounding of systems.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 12/14/2025, the firm emailed an "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" Letter to customer informing them that Elekta has identified a safety issue relating to the modulator discharge rod, where the supplier has been fitting the crimp in the crimp tool back to front. The issue was discovered during production. Note - The discharge rod is used by Field Service Engineers (FSE) when completing service activities on the machine around the HT and RF (High Tension (high voltage) and Radio Frequency) assembly. Instructions to customer: No actions are required to be taken by the Clinical user. Instructions for Field Service Engineers: Possible impact on the Field Service Engineer:- The FSE uses the HT discharge rod to fully discharge the voltage capacitor. Once the FSE has completed the procedure using the discharge rod, the FSE will start to work on the system around the HT and RF assembly. If the discharge rod is not fully connected to the ground or not connected at all, the system will still be fully charged and the FSE could receive an electric shock. Elekta will release an Important Field Safety Modification (IFSM) to identify potentially faulty discharge rod crimping and provide further instructions. The IFSM will include procedures for verifying the reliability of the discharge rod crimping and replacing affected components if necessary. local Elekta service representative will contact you to arrange for this activity to be completed.
Quantity in commerce: 5391
Distribution: Worldwide
Product codes and lots: Lot Code: 05060191071550 (NFB) Elekta Synergy 05060191071505 (FB) 05060191071543 (NFB) Elekta Infinity 05060191071512 (FB) 05060191071574 (NFB) Versa HD 05060191071529 (FB) 05060191071581 Harmony 05060191071604 Harmony Pro 07340201503461 Elekta Evo

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1164-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1164-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-23

Product code IYE

K210500Class IIElekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDElekta Limited / cleared 2021-06-11

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)