Elekta, Inc. recalls Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy

Elekta Medical linear accelerators — Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD, Harmony Pro and Elekta Evo — with the listed lot codes (for example 05060191071550 NFB; 05060191071505 FB; 05060191071543 NFB; 05060191071512 FB; 05060191071574 NFB; 05060191071529 FB; 05060191071581; 05060191071604; 07340201503461) are affected. The devices were recalled because of a manufacturing issue and electrical grounding of systems. The recall covers 5,391 units sold worldwide.

What's being recalled

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

Recalling firm: Elekta, Inc., Atlanta, GA, United States.

How to identify it

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

The hazard

Due to a manufacturing issue and electrical grounding of systems.

What to do

Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.

The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.

Where it was sold

Worldwide

The official notice

This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.

Read the official notice (opens in a new tab)