Elekta Oncentra Brachy software recalled for incorrect dose calculation errors
Elekta, Inc. is recalling Oncentra Brachy radiation therapy planning software because it may calculate incorrect doses for specific regions of interest.
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 involves a medical device with a defect that could lead to incorrect radiation dosing, a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Elekta, Inc. is recalling 351 units of Oncentra Brachy radiation therapy planning software. The software is designed to analyze and plan three-dimensional radiation treatments for patients with cancer. The recall is due to a defect where the software may calculate incorrect doses for Regions of Interest (ROIs) defined on a secondary image series.
The affected software builds are 3.3, 4.0, 4.1, and 4.3. The units were distributed to facilities in numerous U.S. states and international locations, including Argentina, Australia, Canada, China, and Japan. The source text does not specify the number of patients affected or report any injuries or illnesses resulting from the use of the software.
Healthcare providers should contact Elekta, Inc. for instructions on how to address the defect. The source text does not provide specific consumer instructions or a deadline for the recall.
The recalled product
- Product
- Oncentra Brachy radiation therapy 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
- 351
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 (5)
- MUJ/892.5050
- Software Builds - 3.3
- 4.0
- 4.1
- 4.3
Distribution
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