Elekta Oncentra Radiation Therapy Software Recalled for Cross Profile Defect
Elekta, Inc. is recalling Oncentra External Beam and Brachy software because a cross profile for a Varian 60-degree wedge shows 'horns.' The recall covers 433 units distributed worldwide.
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, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The specific defect involves a software visualization issue ('horns' in the cross profile) which poses a risk of harm to patients if the planning software is used incorrectly, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Elekta, Inc. is recalling Oncentra External Beam and Oncentra Brachy radiation therapy planning software. The recall was initiated because a cross profile for a Varian 60-degree wedge shows 'horns.' The software is designed to analyze and plan radiation treatment in three dimensions for the purpose of treating patients with cancer.
The recall affects 433 units of the software, covering all software builds. The products were distributed worldwide, including in the United States (AL, CA, DC, NE, NY, ND, OR, PA, RI, SC, TX) and numerous international countries such as Australia, Canada, China, France, Germany, India, Japan, and the United Kingdom.
The FDA has classified this recall as Class II. Consumers and healthcare providers should contact Elekta, Inc. for further instructions regarding the recall and any necessary software updates or corrections.
The recalled product
- Product
- Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating patients with cancer.
- Manufacturer
- Elekta, Inc.
- Affected units
- 433
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)
- All software builds
Distribution
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