Brainlab ExacTrac Vero Radiation Therapy System Recall for Positioning Error
Brainlab is recalling ExacTrac Vero systems because a software error may cause the treatment couch to miss the planned position, potentially affecting radiation therapy accuracy.
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 risk-of-harm product (radiation therapy positioning) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Brainlab AG is recalling 28 units of the ExacTrac Vero system, a medical device used in conjunction with the MHI-TM2000 Radiation Therapy Linear Accelerator System. The affected units are ExacTrac Vero software versions 3.5(.x), specifically catalog numbers 46228, 46238, 46216, and 46218. The system is intended to analyze patient position and calculate necessary correction shifts for the radiation therapy couch.
The recall was initiated after Brainlab internally detected that under specific conditions, the ExacTrac Vero software may not correctly account for ring angle corrections during the calculation of the couch shift. This error may result in the treatment couch not moving to the exact planned position, creating a deviation between the planned and actual treatment target position. The source notes that this deviation may not be clearly visible to the user if a verification image of the patient position is not acquired after the couch shift is performed.
The affected units were distributed worldwide, including in the United States, Belgium, Canada, France, Germany, Italy, Japan, and South Korea. The source text does not provide specific instructions for consumers or healthcare providers on how to resolve the issue, nor does it report any illnesses or injuries associated with this defect.
The recalled product
- Product
- BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4 The ExacTrac Vero system is intended to be used in conjunction with the MHI-TM2000 Rad
- Manufacturer
- Brainlab AG
- Affected units
- 28
Distribution
Distribution scope not specified by the agency.
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