Elekta Unity Radiation Therapy System Software Recall
Elekta is recalling 12 Unity systems because a software defect prevents users from inspecting stored alignment values during quality assurance.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a software defect preventing inspection of alignment values, which is a procedural or quality control issue rather than a direct, reported physical injury or high-risk pathogen exposure.
Plain-English summary
Elekta, Inc. is recalling 12 units of the Elekta Unity Image-Guided Radiation Therapy System. The recall is due to a defect in the quality assurance (QA) software solution used to perform the MR to MV alignment check. The software fails to display the stored MR to MV offset values, which prevents users from independently inspecting these values during their QA procedures.
The affected units were distributed in the United States to Texas and Wisconsin, and internationally to Canada, Denmark, Germany, Italy, the Netherlands, Sweden, and the United Kingdom. The specific units are identified by UDI/GTIN 5060081071321 and various installed product serial numbers listed in the agency record.
This recall addresses a software limitation that affects the ability to verify alignment data. No specific instructions for end-users are provided in the source text, but the defect impacts the quality assurance process for the radiation therapy system.
The recalled product
- Product
- Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical…
- Manufacturer
- Elekta, Inc.
- Affected units
- 12
Distribution
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