Brainlab RT Elements Software Recalled for Incorrect Dose Calculation
Brainlab AG is recalling specific versions of RT Elements software due to a potential for incorrect dose distribution calculations when using the Pencil Beam algorithm on the GPU.
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 radiation dose calculations, posing a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Brainlab AG is recalling specific versions of its RT Elements software applications, including Cranial SRS, Spine SRS, Multiple Brain Mets SRS, and RT QA. The affected software versions are 1.0.0 and 1.5.0 for Cranial SRS, Spine SRS, and RT QA, and version 1.5.0 for Multiple Brain Mets SRS.
The recall is issued because there is a potential for an incorrect dose distribution calculation under specific circumstances. This issue occurs when using the Pencil Beam algorithm on the GPU (graphics card), which is the default system setting for these applications. The software is used for radiation treatment planning for stereotactic, conformal, and computer-planned Linac-based radiation treatment of cranial, head and neck, and extracranial lesions.
The recall affects 164 units in the United States and 333 units outside the US. Distribution was worldwide, including nationwide distribution in the US across multiple states and various international locations. Users of the affected software should contact Brainlab AG for further instructions on corrective actions.
The recalled product
- Product
- RT Elements Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected: - Cranial SRS 1.0.0 and 1.5.0 - Spine SRS 1.0.0 and 1.5.0 - Multiple Brain Mets SRS 1.5.0…
- Manufacturer
- Brainlab AG
Distribution
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