Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD
Summary
The FDA issued a Class II for Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Ele by Elekta, Inc.. Reason: Due to a manufacturing issue and electrical grounding of systems..
Details
Source
Device Recall
External ID
Z-1164-2026
Action Date
2026-02-04
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: 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
Quantity Affected: 5391
Reason for Recall
Due to a manufacturing issue and electrical grounding of systems.
Distribution
Worldwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-14
Company
Atlanta, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 175 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Elekta, Inc. has 24 FDA actions in our database, including 24 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Elekta, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Elekta, Inc. have FDA actions?
Elekta, Inc. has 24 FDA actions in our database, including 24 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1164-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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