Brainlab ExacTrac Dynamic Radiation Therapy System Software Recall
Brainlab AG is recalling ExacTrac Dynamic radiation therapy systems due to a software error that may allow treatment despite exceeding position tolerances.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device defect that could lead to significant injury by allowing radiation treatment to proceed despite incorrect patient positioning.
Plain-English summary
Brainlab AG is recalling 73 ExacTrac Dynamic Medical Charged-Particle Radiation Therapy Systems (versions 1.0.0, 1.0.1, and 1.0.2) in the United States and internationally. The affected systems were distributed to facilities in California, New Jersey, Arizona, Arkansas, New York, Indiana, Oregon, and North Carolina, as well as in Australia, Austria, Belgium, Denmark, France, Germany, Hong Kong, Italy, Slovakia, Spain, Thailand, Turkey, the United Kingdom, and the United Arab Emirates.
The recall is due to a software error that can occur if automatic marker detection fails. This error may cause parts of the display to incorrectly indicate that the patient's position is within predefined tolerances, potentially allowing the user to proceed with treatment even if shift values are exceeded.
Healthcare facilities using these systems should contact Brainlab AG for instructions on how to resolve the software issue. The recall is classified as Class II by the FDA.
The recalled product
- Product
- ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
- Manufacturer
- Brainlab AG
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 (2)
- 1.0.1
- 1.0.2.
Distribution
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