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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- 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
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