ExacTrac Dynamic 1.1Recalls & reported problems
Brainlab SE · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056481143978), received between Jul 26, 2023 and Jul 26, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- 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 · FDA record ↗
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.