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 body when radiation tre
Check against the official notice below — it lists the full affected range.
Brainlab AG is recalling 587 ExacTrac Patient Positioning System units worldwide, affecting versions 6.0, 6.1, 6.2, and 6.5 used in stereotactic radiosurgery procedures. The systems are designed to position patients accurately within a medical accelerator's treatment beam and work with Varian Clinac or Varian TrueBeam equipment through an Auxiliary Device Interface (ADI). The recall addresses a potential safety issue where workflows that differ from the specifications detailed in the User manual may result in misinterpretation of beam authorization through the ADI.
The affected systems are identified by specific license numbers and product codes, with GTINs available for versions 6.2 and 6.5. The recall applies to equipment distributed worldwide. The source document does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
The usage of workflows that deviate from the recommended specifications in the User manual for ExacTrac Patient Positioning System (versions 6.0, 6.1, 6.2, 6.5) with Auxiliary Device Interface (ADI) and Varian Clinac or Varian TrueBeam, which may result in misinterpretation of beam authorization via ADI.
Reason for recall: The usage of workflows that deviate from the recommended specifications in the User manual for ExacTrac Patient Positioning System (versions 6.0, 6.1, 6.2, 6.5) with Auxiliary Device Interface (ADI) and Varian Clinac or Varian TrueBeam, which may result in misinterpretation of beam authorization via ADI. Distribution: worldwide Quantity: 587 systems Lot/code info: UDI: GTIN for ExacTrac 6.0 and 6.1 is not applicable GTIN for ExacTrac 6.2 is: 04056481000264 GTIN for ExacTrac 6.5 is: 04056481138400 License No. Description 20833 EXACTRAC 6.0 IR POSITIONING SOFTWARE 20834 EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE 20835 EXACTRAC 6.0 IR MONITORING SOFTWARE 20853 EXACTRAC 6.0 X-RAY LIMITED SOFTWARE 20871 EXACTRAC 6.1 X-RAY POSITIONING SOFTWARE 20872 EXACTRAC 6.1 IR POSITIONING SOFTWARE 20873 EXACTRAC 6.1 X-RAY MONITORING SOFTWARE 20874 EXACTRAC 6.1 X-RAY LIMITED SOFTWARE 20881 EXACTRAC 6.2 X-RAY POSITIONING SOFTWARE 20884 EXACTRAC 6.2 X-RAY LIMITED SOFTWARE 20833A EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833C EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833D EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833E EXACTRAC 6.0 IR POSITIONING SOFTWARE 20834A EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE 20834B EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE 20834C EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE 20834D EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE 20834E EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE 20835A EXACTRAC 6.0 IR MONITORING SOFTWARE 20835B EXACTRAC 6.0 IR MONITORING SOFTWARE 20835C EXACTRAC 6.0 IR MONITORING SOFTWARE 20835D EXACTRAC 6.0 IR MONITORING SOFTWARE 20835E EXACTRAC 6.0 IR MONITORING SOFTWARE 20853A EXACTRAC 6.0 X-RAY LIMITED SOFTWARE 20853B EXACTRAC 6.0 X-RAY LIMITED SOFTWARE 20853C EXACTRAC 6.0 X-RAY LIMITED SOFTWARE 20853D EXACTRAC 6.0 X-RAY LIMITED SOFTWARE 20853E EXACTRAC 6.0 X-RAY LIMITED SOFTWARE 20871A EXACTRAC 6.1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.