ExacTrac Dynamic 2.0Recalls & reported problems
Brainlab SE · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056481144609), received between Jan 16, 2026 and Jan 16, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Unintended Radiation Exposure1
Recent adverse event reports
The 1 most recent of 1 reports, 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 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.