Exactrac 6.2Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04056481000264), received between Jun 2, 2017 and May 7, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (3 reports).

1 FDA recall record name this device's identifier.

5 other recalls cover devices cleared under the same FDA submission (K120789); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Feb 14, 2018Terminated

   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.

   Z-1006-2018 · Root cause: Other · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2024Use of Device Problem; Use of Device Problem

  A STEREOTACTIC BODY RADIOTHERAPY (SBRT) TREATMENT WAS CONDUCTED TARGETING A SPINE TUMOUR LOCATED AT VERTEBRA L4 WITH 2 PLANNING TARGET VOLUMES (PTVS), AN INTEGRATED BOOST WITH 4.3CM³ AND THE TOTAL VERTEBRAL BODY HAVING 61CM³, EACH WITH 3 FRACTIONS. THE OVERALL DOSE PLANNED WAS 27 GY TO THE BOOST-VOLUME AND 21 GY TO THE VERTEBRAL BODY, WITH A DOSE PER FRACTION OF 7 GY AND 9 GY. THE EXACTRAC PATIENT POSITIONING SYSTEM VERSION 6.2 WAS USED TO POSITION THE PATIENT FOR TREATMENT ON A NON-BRAINLAB LINEAR ACCELERATOR (LINAC) EQUIPPED WITH A BRAINLAB ROBOTICS TABLE TOP. DURING THE RADIATION TREATMENT THE THERAPISTS: - PLACED THE PATIENT ON THE COUCH OF THE NON-BRAINLAB LINEAR ACCELERATOR (LINAC). - ACQUIRED KILOVOLTAGE (KV) IMAGING X-RAY PAIRS, THEN USED EXACTRAC TO VERIFY THE POSITION OF THE PATIENT. - PREPARED ONE OF THE SETUP BEAMS BY MISTAKE WHILE APPLYING THE INITIAL COUCH SHIFT TO POSITION THE PLANNED TARGET IN THE PATIENT INTO THE ISOCENTER OF THE LINAC. - DETERMINED THAT THE SHIFTS DID NOT GO THROUGH. - ACQUIRED VERIFICATION X-RAY IMAGES ONCE THE TREATMENT POSITIONING WAS COMPLETED. - DETERMINED THAT THEY WERE TARGETING A DIFFERENT LOCATION THAN INTENDED. - RESTARTED THE PATIENT PO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19258874 ↗
• InjuryAug 24, 2022Use of Device Problem; Use of Device Problem

  A SINGLE FRACTION CRANIAL RADIATION TREATMENT FOR A PALLIATIVE RADIOSURGERY OF A BRAIN METASTASIS LOCATED FRONT PARIETAL CA. 7CM DEEP WITH A SIZE OF CA. 4CCM, FROM SMALL CELL NEUROENDOCRINE LUNG CANCER, WITH INTENDED 10 STATIC BEAMS OF 2X2CM DELIVERING 18GY, HAS BEEN PERFORMED AT A LINEAR ACCELERATOR USING THE BRAINLAB EXACTRAC PATIENT POSITIONING SYSTEM VERSION 6.2. DURING THE RADIATION TREATMENT THE THERAPISTS: - PLACED THE PATIENT ON THE COUCH OF THE NON-BRAINLAB LINEAR ACCELERATOR (LINAC). - OPENED THE POSITIONING PLAN IMPORTED INTO EXACTRAC. - FIRST FOR THE 5 BEAMS AT COUCH ANGLE 0°, ACQUIRED X-RAYS WITH EXACTRAC AND FUSED THESE TO THE DIGITALLY RECONSTRUCTED RADIOGRAPHS (DRRS) CALCULATED BY EXACTRAC FROM A PRE-TREATMENT CT SCAN CONTAINING THE PLANNED TARGET. - APPLIED THE CALCULATED COUCH SHIFT FROM EXACTRAC TO POSITION THE PLANNED TARGET IN THE PATIENT INTO THE ISOCENTER OF THE LINAC. - ACQUIRED VERIFICATION X-RAYS OF THE CURRENT TREATMENT POSITION, FUSED THESE AGAIN TO THE DRRS, AND APPLIED A FURTHER SMALL POSITION CORRECTION CALCULATED BY EXACTRAC TO THE LINAC COUCH WITH THE PATIENT ON IT. - REPEATED THE X-RAY VERIFICATION WITH EXACTRAC, AND AUTHORIZED THE RADIATION TREATM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15281318 ↗
• MalfunctionAug 28, 2020Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  A PATIENT WAS INTENDED TO BE POSITIONED FOR A FRACTIONATED 4 ARC STEREOTACTIC RT TREATMENT FOR A VESTIBULAR SCHWANNOMA WITH BRAINLAB EXACTRAC PATIENT POSITIONING SYSTEM (VERSION 6.2.0) AND VARIAN TRUEBEAM RADIOTHERAPY SYSTEM (VERSION 2.7MR2.1) USING THE AUXILIARY DEVICE INTERFACE (ADI). ADI IS UTILIZED TO SEND COUCH MOVE REQUESTS FROM EXACTRAC TO THE TREATMENT APPLICATION AND TO AUTHORIZE BEAM REQUESTS OF THE TREATMENT APPLICATION BY EXACTRAC. WHEN A PATIENT IS LOADED BY EXACTRAC, EXACTRAC VERIFIES THE POSITION OF THE PATIENT, AND ONLY AUTHORIZES BEAM REQUESTS IF THE PATIENT IS CORRECTLY POSITIONED (I.E. OK ICON VISIBLE ON EXACTRAC SCREEN). EXACTRAC CALCULATES TRANSLATIONAL AND ROTATIONAL SHIFTS; THE ROTATIONAL SHIFTS ARE APPLIED BY THE BRAINLAB ROBOTICS. FOR THIS SPECIFIC TREATMENT, THE PATIENT PLAN WAS OPENED ON THE VARIAN TRUEBEAM AND BRAINLAB EXACTRAC SOFTWARE. AFTER PREPOSITIONING OF THE PATIENT, THE CORRECTION SHIFTS (TRANSLATION AND ROTATION) FOR EXACT PATIENT POSITIONING HAVE BEEN CALCULATED BY EXACTRAC WITH THE X-RAY CORRECTION STEP. THE CALCULATED ROTATIONAL SHIFTS (PITCH AND ROLL) WERE WITHIN THE SPECIFIED TOLERANCE FOR THIS SITE. THUS THE USER CANCELLED THE REQUESTED RO

  Patient problems: No Clinical Signs, Symptoms or Conditions; Radiation Overdose; Unintended Radiation Exposure

  MAUDE report 10465355 ↗
• MalfunctionDec 22, 2017Inadequate Instructions for Healthcare Professional; Insufficient Device Problem Information; Inadequate Instructions for Healthcare Professional; Insufficient Device Problem Information

  A PATIENT WAS INTENDED TO BE POSITIONED FOR A PROSTATE RT TREATMENT ON (B)(6) 2017 WITH BRAINLAB EXACTRAC PATIENT POSITIONING SYSTEM (VERSION 6.2) AND VARIAN TRUEBEAM RADIOTHERAPY SYSTEM (VERSION 2.5), USING THE AUXILIARY DEVICE INTERFACE (ADI). ADI IS UTILIZED TO SEND COUCH MOVE REQUESTS FROM EXACTRAC TO THE TREATMENT APPLICATION AND TO AUTHORIZE BEAM REQUESTS OF THE TREATMENT APPLICATION BY EXACTRAC. AS LONG AS NO PATIENT IS LOADED WITHIN EXACTRAC, IT ALWAYS AUTHORIZES EVERY REQUEST FROM THE TRUEBEAM SIDE. WHEN A PATIENT IS LOADED BY EXACTRAC, EXACTRAC VERIFIES THE POSITION OF THE PATIENT AND ONLY AUTHORIZES BEAM REQUESTS IF THE PATIENT IS CORRECTLY POSITIONED (I.E. OK ICON VISIBLE ON EXACTRAC SCREEN). FOR THIS SPECIFIC TREATMENT THE PATIENT HAS BEEN OPENED ON THE VARIAN TRUEBEAM AND A MESSAGE BOX FOR PATIENT OPENING WAS DISPLAYED IN EXACTRAC. A BEAM WAS SELECTED ON TRUEBEAM AND AFTERWARDS THE MESSAGE BOX IN EXACTRAC WAS ACKNOWLEDGED BY CLICKING "OPEN", WHICH OPENED AUTOMATICALLY THE PATIENT IN THE EXACTRAC SOFTWARE. AFTER PREPOSITIONING OF THE PATIENT THE CORRECTION SHIFTS FOR EXACT PATIENT POSITIONING HAVE BEEN CALCULATED BY EXACTRAC WITH THE X-RAY CORRECTION STEP. THE CALCULAT

  Patient problems: No Known Impact Or Consequence To Patient; Radiation Overdose

  MAUDE report 7141576 ↗
• MalfunctionSep 6, 2017Improper or Incorrect Procedure or Method; Device Handling Problem; Improper or Incorrect Procedure or Method; Device Handling Problem

  A PATIENT WAS TREATED IN A NOT-INTENDED POSITION DURING AN EXACTRAC WORKFLOW. ·THE CUSTOMER USED EXACTRAC 6.1.1 FOR PATIENT POSITIONING FOR A CRANIAL RT TREATMENT. ·AS PART OF THE X-RAY CORRECTION STEP IN THE WORKFLOW, THE SOFTWARE CALCULATED CORRECTION SHIFTS WHICH WERE SENT TO THE ROBOTICS COUCH AS USUAL. THE MOVEMENT OF THE ROBOTICS COUCH WAS INTERRUPTED, RESULTING IN THE TARGET POSITION NOT BEING REACHED. ·THE USER SUBSEQUENTLY ENTERED THE X-RAY VERIFICATION STEP AND PERFORMED AN IMAGE FUSION OF POOR ACCURACY (THE X-RAY AND DRR IMAGES DID NOT MATCH SPATIALLY). THE RESULTANT FAULTY VERIFICATION SHIFTS WERE APPLIED BY ROBOTICS AND THE COUCH. ·THIS RESULTED IN A NON-OPTIMAL POSITIONING OF THE PATIENT FOR THE CRANIAL RT TREATMENT. A TREATMENT FRACTION WAS DELIVERED TO THE PATIENT. A SINGLE FRACTION OUT OF 25 WAS DELIVERED TO A NOT-INTENDED LOCATION, NO NEGATIVE CLINICAL EFFECTS TO THE PATIENT HAVE THUS FAR BEEN REPORTED. PER THE CUSTOMER, THE TREATMENT OF THE PATIENT CONSISTS OF 25 FRACTIONS (I.E. NOT RADIOSURGERY), NO MEDICAL INTERVENTION WAS NECESSARY OR IS PLANNED AND THE TREATMENT IS CONTINUED WITH EXACTRAC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6844999 ↗
• MalfunctionJun 2, 2017Improper or Incorrect Procedure or Method; Human Factors Issue; Device Handling Problem; Improper or Incorrect Procedure or Method; Human Factors Issue; Device Handling Problem

  THE HOSPITAL INFORMED BRAINLAB THAT ON A SINGLE DAY, THE USER PERFORMED RADIOTHERAPY TREATMENT OF THREE PATIENTS. PRIOR TO THE PATIENT TREATMENT, THE BRAINLAB EXACTRAC 6.2.0 DEVICE WAS CALIBRATED BY THE USER TO AN ISOCENTER DEVIATING BY APPROXIMATELY 11 MM IN VERTICAL DIRECTION FROM THE ROOM LASER CROSSING. THE USER PLACED MANUAL MARKINGS WHERE THE ROOM LASER WAS EXPECTED TO LAND. FOR ALL THREE PATIENTS, THE MARKINGS DID NOT MATCH WELL TO THE LASERS WHEN THE PATIENT WAS POSITIONED WITH EXACTRAC 6.2.0. PATIENT 1 AND PATIENT 2 WERE TREATED IN THE POSITION REACHED USING EXACTRAC 6.2.0, DESPITE AWARENESS BY THE USER THAT THE MARKINGS DID NOT MATCH THE ROOM LASERS. THEREFORE THE POSITIONING WITH EXACTRAC 6.2.0 RESULTED IN AN INCORRECT TREATMENT POSITION APPROXIMATELY 11 MM BELOW THE CORRECT TREATMENT POSITION FOR THESE PATIENTS. FOR PATIENT 3, THE USER REPORTEDLY BECAME MORE CONCERNED WHEN THE DEVIATION WAS AGAIN VISIBLE, AS IT WAS CONSISTENTLY APPEARING FOR EACH PATIENT THAT DAY. THE USER DECIDED TO VERIFY THE TREATMENT POSITION BEFORE TREATMENT OF PATIENT 3 WITH THE NON-BRAINLAB VARIAN KV IMAGING, AND DISCOVERED A DISCREPANCY BETWEEN THE EXACTRAC 6.2.0 POSITION AND THE INTENDED TREATM

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6607682 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120789. One submission often covers many models, so check the product and lot details in each record.

• Z-2440-2015 · Aug 5, 2015 · Terminated
  ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerat
• Z-1582-2015 · Mar 6, 2015 · Terminated
  ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy pro
• Z-1316-2015 · Feb 16, 2015 · Terminated
  ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..
• Z-2146-2014 · Jun 24, 2014 · Terminated
  ExacTrac is 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 pr
• Z-1513-2014 · Feb 24, 2014 · Terminated
  ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49926B ET