Nucletron Oncentra Brachy 4.5 Software Recalled for Incorrect Source Step Size
Nucletron BV is recalling Oncentra Brachy 4.5 radiation therapy software because incorrect source step sizes may occur in treatment plans.
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 software defect that could lead to incorrect treatment planning for cancer patients. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported, and it is not classified as FDA Class I.
Plain-English summary
Nucletron BV is recalling Oncentra Brachy 4.5 radiation therapy software, including versions 4.5, 4.5.1, and 4.5.2. The software is designed to analyze and plan three-dimensional radiation treatments for patients with cancer. The recall is due to a defect where incorrect source step sizes may occur in the software plans.
The affected software is distributed worldwide to medical facilities in the United States and numerous other countries, including Canada, Australia, and the United Kingdom. There was no military or government distribution. A total of 89 customer sites have the affected software.
No specific consumer actions are detailed in the source text beyond the recall notification. Medical facilities should be aware that the treatment plans generated by this software may contain errors in source step size, which could impact the accuracy of the dose distribution estimates used for patient treatment.
The recalled product
- Product
- Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment…
- Manufacturer
- Nucletron BV
- Affected units
- 89
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 (3)
- Versions 4.5
- 4.5.1
- and 4.5.2.
Distribution
Distributed nationwide across the United States.
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