Brainlab ExacTrac Software Recall for Beam Authorization Misinterpretation Risk
Brainlab AG is recalling ExacTrac Patient Positioning System software versions 6.0 through 6.5 due to a risk of misinterpreting beam authorization when used with specific Varian accelerators.
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 is classified as FDA Class II and involves a risk of harm (misinterpretation of beam authorization) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Brainlab AG is recalling 587 ExacTrac Patient Positioning System software systems, versions 6.0, 6.1, 6.2, and 6.5. These systems are used to position patients for stereotactic radiosurgery or radiotherapy procedures. The recall is due to a potential risk of misinterpreting beam authorization via the Auxiliary Device Interface (ADI) when the software is used with Varian Clinac or Varian TrueBeam accelerators.
The hazard arises from the usage of workflows that deviate from the recommended specifications in the User manual. This deviation may result in the misinterpretation of beam authorization signals. The affected software was distributed worldwide.
Healthcare facilities using these systems should contact Brainlab AG for instructions on how to address the issue. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the…
- Manufacturer
- Brainlab AG
- Affected units
- 587
Distribution
Distribution scope not specified by the agency.
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