Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Oncentra Brachy radiation therapy planning system software. Recalled by Elekta, Inc. Due to A reconstruction error may occur when using the...

Date: December 5, 2022
Company: Elekta, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Elekta, Inc. directly.

Affected Products

Oncentra Brachy radiation therapy planning system software.

Quantity: 336 systems

Why Was This Recalled?

A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Elekta, Inc.

Elekta, Inc. has 100 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report