Recall Z-1006-2018 ยท IYE Accelerator, Linear, Medical
Brainlab AG
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 treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.
| Date | Feb 14, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | The firm disseminated their notices by email on 02/14/2018. The notice requests the following actions: "User Corrective Action: Always follow the instructions below during use of ExacTrac Patient Positioning System (versions 6.0, 6.1, 6.2, 6.5) with Auxiliary Device Interface (ADI) and Varian Clinac or Varian TrueBeam: Do not use beam authorization by ExacTrac via ADI as a safety feature to ensure correct patient positioning before treatment. For any treatments performed with ExacTrac always verify that ExacTrac confirms the target position by displaying the OK icon. Do not treat the patie |
| Quantity | 587 systems |
| Distribution | worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120789 | EXACTRAC X-RAY X-RAY Brainlab AG, Aug 14, 2012 |