Brainlab Brain Metastases Software Recall for Image Display Errors
Brainlab AG is recalling Brain Metastases 1.0.0 software because large objects may display cropped during import.
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, which typically corresponds to a Moderate severity score when no specific hospitalizations or severe injuries are reported in the source text.
Plain-English summary
Brainlab AG is recalling 20 systems of Brain Metastases version 1.0.0 software. This software is used for radiation treatment planning for cranial, head and neck, and extracranial lesions. The recall is due to a defect where large objects with fine resolution are potentially displayed cropped when imported into the application.
The affected software was distributed worldwide, including in the United States and internationally to Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Mexico, Portugal, South Korea, Spain, Switzerland, Turkey, and the United Kingdom. The specific model and catalogue numbers affected are listed in the recall documentation.
Healthcare providers should contact Brainlab AG for instructions on how to address the software defect. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor…
- Manufacturer
- Brainlab AG
- Category
- Medical Device — Software
- Affected units
- 20
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Brainlab AG under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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