ExacTrac DynamicRecalls & reported problems across all models

We found 2 models of ExacTrac Dynamic by Brainlab SE in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Jul 26, 2023 and Jan 16, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

ExacTrac Dynamic recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Feb 14, 2023Open, Classified

   Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template

   Z-1259-2023 · Root cause: Software design · Recall details · FDA record ↗

Most reported ExacTrac Dynamic problems

ExacTrac Dynamic models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ExacTrac Dynamic 1.1

  Accelerator, Linear, Medical
  1 recall1 report
• ExacTrac Dynamic 2.0

  Accelerator, Linear, Medical
  1 report

Recent ExacTrac Dynamic adverse event reports

The 2 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2026Use of Device Problem

  AN SBRT TREATMENT ON THE LIVER WAS PERFORMED USING A NON-BRAINLAB CBCT POSITIONING SYSTEM TOGETHER WITH THE EXACTRAC DYNAMIC 2.0 SYSTEM (ETD), USING ONLY SURFACE MONITORING CAPABILITIES. FOR THE PREPOSITIONING A TREATMENT BEAM WAS LOADED ON THE NON-BRAINLAB LINAR ACCELERATOR (LINAC) AND THE PREPOSITIONING WAS PERFORMED WITH EXACTRAC DYNAMIC 2.0. AFTER COMPLETING THE PREPOSITIONING, THE USER ACTIVELY CONFIRMED BY PRESSING THE "POSITIONING FINISHED" BUTTON INSIDE THE ETD SYSTEM, THAT THE PATIENT POSITIONING WITH A NON-BRAINLAB POSITIONING SYSTEM (CBCT) WAS COMPLETED, DESPITE IT WAS NOT PERFORMED YET. IN A SECOND STEP THE USER INADVERTENTLY ACTIVATED THE RADIATION BEAM AT THE NON-BRAINLAB LINAC, INSTEAD OF LOADING THE CBCT SETUP FIELD. THE USER IMMEDIATELY RECOGNIZED THE MISTAKE AND TURNED OFF THE BEAM. 50,8MU OF 3076.5MU (1 OUT OF 5 FRACTIONS) WERE DELIVERED TO THIS INITIAL POSITION, WHICH WAS 19,1 MM AWAY FROM THE ACTUAL TREATMENT POSITION. ACCORDING TO THE TREATING CLINICIAN, THE AMOUNT OF RADIATION TREATMENT DOSE DELIVERED TO A DIFFERENT LOCATION THAN INTENDED AS WELL AS THE DOSE DEVIATION TO THE PLANNED TARGET, CAN BE CONSIDERED NEGLECTABLE COMPARED TO THE OVERALL FRACTIONATED TR

  Patient problems: Unintended Radiation Exposure

  MAUDE report 24092782 ↗
• InjuryJul 26, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  THE USER DETECTED ON THE EVENING OF (B)(6) 2023 THAT THE EXACTRAC DYNAMIC SYSTEM THEY HAD USED TO TREAT PATIENTS DURING THE DAY HAD BEEN INCORRECTLY CALIBRATED ON THE MORNING OF THAT SAME DAY. THE INCORRECT CALIBRATION LED TO A DEVIATION OF PATIENT POSITIONING (DISTANCE FROM ISOCENTER 10.22 MM), AND 6 PATIENT TREATMENTS WERE AFFECTED (5 TREATMENTS OF GLIOBLASTOMA, 1 STEREOTACTIC RADIOSURGERY TREATMENT OF THE OPERATING CAVITY AFTER EXCISION OF SECONDARY VERMIAN LESION OF COLON CARCINOMA). THE SYSTEM WAS CORRECTLY CALIBRATED BY THE USER ON THE EVENING OF (B)(6) 2023. ACCORDING TO THE HOSPITAL/PHYSICIST: DESPITE DOSE WAS APPLIED INCORRECTLY (TO INCORRECT TARGET COMPARED TO THE INTENDED DOSE DISTRIBUTION). THERE WAS NO OVERDOSE, ESP. NONE THAT WOULD EXCEED CLINICALLY ACCEPTABLE LIMITS FOR THE SPECIFIC TREATMENTS; ALSO POTENTIAL UNDER-DOSE REMAINED CLINICALLY ACCEPTABLE THERE WAS NO NEGATIVE CLINICAL EFFECT TO THE SPECIFIC PATIENTS, NEITHER OCCURRED NOR EXPECTED. THERE WERE NO REMEDIAL ACTIONS DONE, PLANNED OR NECESSARY FOR THE SPECIFIC PATIENTS/TREATMENTS DUE TO THE DOSE NOT APPLIED IN ACCORDANCE WITH THE TREATMENT PLAN (ON BASIS OF THE DOSIMETRIC ESTIMATION PERFORMED, THE DOCTOR DECID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17395264 ↗

Other Brainlab SE products

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• Spine & Trauma Navigation2 models · 139 reports
• Navigation Software Spine & Trauma 3D2 models · 108 reports
• Cranial2 models · 64 reports
• Exactrac2 models · 6 reports · 1 recall
• Origin Data Management / Patient Data Manager2 models · 0 reports · 1 recall
• Spine Srs2 models · 0 reports · 1 recall