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 Radiation Therapy Linear Acceler
Check against the official notice below — it lists the full affected range.
Brainlab AG is recalling ExacTrac Vero systems (28 units distributed worldwide including the US, Belgium, Canada, France, Germany, Italy, Japan, and South Korea) because the device may not correctly account for ring angle corrections when calculating treatment couch movements under specific conditions. This can result in the treatment couch not moving to the exact planned position, creating a deviation between where the treatment is planned and where it is actually delivered.
The deviation between the planned and actual treatment target position may not be easily noticed by users unless a verification image of the patient's position is acquired after the couch movement. The recall affects ExacTrac Vero versions 3.x, with ExacTrac Vero software versions 3.5 and later currently in use. The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Brainlab has internally detected that under specific conditions ExacTrac Vero may not correctly account for this ring angle correction during the calculation of the corresponding couch shift. This may result in the treatment couch not moving to the exact planned position resulting in a deviation between the planned and the treatment target position. This deviation may not be clearly visible to the user if no verification image of the patient position is acquired after this couch shift has been performed.
Reason for recall: Brainlab has internally detected that under specific conditions ExacTrac Vero may not correctly account for this ring angle correction during the calculation of the corresponding couch shift. This may result in the treatment couch not moving to the exact planned position resulting in a deviation between the planned and the treatment target position. This deviation may not be clearly visible to the user if no verification image of the patient position is acquired after this couch shift has been performed. Distribution: Worldwide Distribution - US Distribution and to the countries of : Belgium, Canada, France, Germany, Italy, Japan and S. Korea Quantity: 28 units Lot/code info: Potentially affected are ExacTrac Vero versions 3.x. Currently only ExacTrac Vero SW versions 3.5(.x) are installed for use on existing ExacTrac Vero Systems (only ExacTrac Vero v.3.5 exist in the field). UDI: 04056481132446
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.