The Recall Desk
HighFDA (Devices)·Z-0604-2016·Announced 2016-01-13

Elekta Oncentra VMAT Radiation Therapy Planning System Recalled for Software Error

Elekta, Inc. is recalling 154 units of the Oncentra External Beam - VMAT radiation therapy planning system because a software error may cause the system to incorrectly include organs at risk as target volumes.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a software error in a medical device used for cancer treatment that could lead to incorrect radiation delivery, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Elekta, Inc. is recalling 154 units of the Oncentra External Beam - VMAT radiation therapy planning system. This software is used to analyze and plan three-dimensional radiation treatments for patients with cancer. The recall covers versions 3.3 and higher.

The recall was initiated because, in rare cases, using the "Tumor Overlap Fraction" option in VMAT planning may cause the system to incorrectly include an organ at risk as a target volume. This error could result in open MLC (multi-leaf collimator) and open jaws in areas away from the intended target volume.

The affected units were distributed worldwide, including in the United States (California, New York, and Pennsylvania) and in Austria, Belarus, Canada, China, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, the Netherlands, Norway, Poland, South Korea, Spain, Sweden, and the United Kingdom. Users of this software should contact Elekta, Inc. for further instructions on how to address the issue.

The recalled product

Product
Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
Manufacturer
Elekta, Inc.
Category
Medical Device — Radiation Therapy Planning Software
Hazard
Affected units
154

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Versions 3.3 and higher

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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