Brainlab ExacTrac 6.0 Patient Positioning System Recalled for Display Error
Brainlab AG is recalling ExacTrac 6.0.x software due to a potential display error in Digitally Reconstructed Radiographs used for x-ray correction.
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 used for radiation therapy where a software error could lead to incorrect patient positioning. This represents a risk of harm where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Brainlab AG is recalling 361 ExacTrac 6.0.x Patient Positioning Systems. The recall affects software versions 6.0.0 through 6.0.5. The product is intended to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.
The recall is due to a potential display of incorrect Digitally Reconstructed Radiographs (DRR) for x-ray correction and verification. The systems were distributed worldwide, including in the United States and numerous international countries.
Healthcare facilities should contact Brainlab AG for instructions on how to resolve the software issue. No specific consumer action is required for the general public, as this is a medical device used in clinical settings.
The recalled product
- Product
- ExacTrac 6.0.x Patient Positioning System, Radiation therapy. 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.
- Manufacturer
- Brainlab AG
- Affected units
- 361
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 (5)
- Affected are ExacTrac versions 6.0.0 through 6.0.5 (v. 6.0.0
- 6.0.1
- 6.0.2
- 6.0.3
- 6.0.4
Distribution
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