CLASS II ONGOING Device recall · Reported 4 Feb 2026 · FDA Enforcement Report

Medical Linear Accelerator Elekta Synergy, Elekta Harmony recalled

Elekta is recalling Elekta Medical Linear Accelerator Elekta Synergy, Versa HD. The recall was initiated on 14 Dec 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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

Quantity recalled5391

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1164-2026
FDA event ID: 97958
Recalling firm: Elekta, Atlanta, GA
Classification: Class II
Status: Ongoing
Recall initiated: 14 Dec 2025
FDA classified: 23 Jan 2026
Reported: 4 Feb 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

14 Dec 2025	Recall initiated by company
23 Jan 2026	Classified by FDA	+40 days
4 Feb 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to a manufacturing issue and electrical grounding of systems.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

Worldwide

Questions about this recall

Is Medical Linear Accelerator Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD recalled?

Yes. Elekta recalled Medical Linear Accelerator Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD on 14 Dec 2025. The recall is Class II and its status is Ongoing. Recall number Z-1164-2026.

Why was it recalled?

Due to a manufacturing issue and electrical grounding of systems.

Which lots are affected?

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

Where was it sold?

Worldwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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