Brainlab ExacTrac Vero 3.5 Patient Positioning System Recalled for Positioning Errors
Brainlab AG is recalling 27 ExacTrac Vero 3.5 systems due to potentially incorrect positioning when using Implanted Marker Detection.
What this means for you
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 with a risk of incorrect patient positioning, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Brainlab AG is recalling 27 units of the ExacTrac Vero Patient Positioning System, specifically version 3.5 and all its subversions. The recall is due to a software issue that may result in potentially incorrect patient positioning when the Implanted Marker Detection feature is used.
The affected systems were distributed in the United States (Florida, New York, Texas, and Ohio) and in Belgium, France, Germany, Italy, Japan, and South Korea. The recall covers specific software versions and upgrade kits, including model numbers 20892, 20892A, 20892B, 20892C, 20893, 46213, 46214, 46215, 46216, 46228, and 46238.
Healthcare facilities using these systems should contact Brainlab AG for instructions on how to resolve the issue. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- ExacTrac Vero is a Patient Positioning System for Radiation therapy.
- Manufacturer
- Brainlab AG
- Hazard
- Affected units
- 27
Distribution
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