{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Munich",
      "state": "",
      "country": "Germany",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79266",
      "recalling_firm": "Brainlab AG",
      "address_1": "Olof-Palme-Strasse 9",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "worldwide",
      "recall_number": "Z-1006-2018",
      "product_description": "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.",
      "product_quantity": "587 systems",
      "reason_for_recall": "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.",
      "recall_initiation_date": "20180214",
      "center_classification_date": "20180314",
      "termination_date": "20210517",
      "report_date": "20180321",
      "code_info": "UDI:  GTIN for ExacTrac 6.0 and 6.1 is not applicable   GTIN for ExacTrac 6.2 is: 04056481000264   GTIN for ExacTrac 6.5 is: 04056481138400  License No.  Description  20833 EXACTRAC 6.0 IR POSITIONING SOFTWARE  20834 EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE  20835 EXACTRAC 6.0 IR MONITORING SOFTWARE  20853 EXACTRAC 6.0 X-RAY LIMITED SOFTWARE  20871 EXACTRAC 6.1 X-RAY POSITIONING SOFTWARE  20872 EXACTRAC 6.1 IR POSITIONING SOFTWARE  20873 EXACTRAC 6.1 X-RAY MONITORING SOFTWARE  20874 EXACTRAC 6.1 X-RAY LIMITED SOFTWARE  20881 EXACTRAC 6.2 X-RAY POSITIONING SOFTWARE  20884 EXACTRAC 6.2 X-RAY LIMITED SOFTWARE  20833A EXACTRAC 6.0 IR POSITIONING SOFTWARE  20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE  20833C EXACTRAC 6.0 IR POSITIONING SOFTWARE  20833D EXACTRAC 6.0 IR POSITIONING SOFTWARE  20833E EXACTRAC 6.0 IR POSITIONING SOFTWARE  20834A EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE  20834B EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE  20834C EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE  20834D EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE  20834E EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE  20835A EXACTRAC 6.0 IR MONITORING SOFTWARE  20835B EXACTRAC 6.0 IR MONITORING SOFTWARE  20835C EXACTRAC 6.0 IR MONITORING SOFTWARE  20835D EXACTRAC 6.0 IR MONITORING SOFTWARE  20835E EXACTRAC 6.0 IR MONITORING SOFTWARE  20853A EXACTRAC 6.0 X-RAY LIMITED SOFTWARE  20853B EXACTRAC 6.0 X-RAY LIMITED SOFTWARE  20853C EXACTRAC 6.0 X-RAY LIMITED SOFTWARE  20853D EXACTRAC 6.0 X-RAY LIMITED SOFTWARE  20853E EXACTRAC 6.0 X-RAY LIMITED SOFTWARE  20871A EXACTRAC 6.1 X-RAY POSITIONING SOFTWARE  20872A EXACTRAC 6.1 IR POSITIONING SOFTWARE  20873A EXACTRAC 6.1 X-RAY MONITORING SOFTWARE  20874A EXACTRAC 6.1 X-RAY LIMITED SOFTWARE  20881A EXACTRAC 6.5 X-RAY POSITIONING SOFTWARE  20882-02 EXACTRAC 6.2.0 SW LICENSE  20882-02A EXACTRAC 6.2.1 SW LICENSE  20882-02B EXACTRAC 6.5.0 SW LICENSE  20883-02A EXACTRAC 6.2 X-RAY MONITORING SOFTWARE  20883-02B EXACTRAC 6.5 X-RAY MONITORING SOFTWARE  20836 EXACTRAC 6.X VARIAN CBCT LICENSE  20838 EXACTRAC 6.X X-RAY MONITORING LICENSE  25730 ET SW 6.5 - X-RAY MONITORING SUB. FOC  25731 ET SW 6.5 - X-RAY MONITORING SUB.  25734 ET SW - DATA PREP REVIEW 6.5 SUB  48302 ET DATA PREP / REVIEW SYSTEM  48304 ET 6.1 DATA PREP/REVIEW SYSTEM UPG. KIT  48320 ET UPGRADE SOFTWARE 6.0 TO 6.1  48321 ET UPGRADE SOFTWARE 3.X TO 6.1 (IR+XR)  48322 ET UPGRADE SOFTWARE 4.X TO 6.1 (IR+XR)  48327 ET UPGRADE TRUEBEAM 5.5 TO 6.1 LIMITED  48331 EXACTRAC 6.0 LIMITED to 6.1 LIMITED SW  48332 EXACTRAC UPGRADE 6.0 LIMITED TO 6.1  48351 EXACTRAC 6.1 X-RAY MONITORING SOFTWARE  48353 ET SOFTWARE UPDATE 6.0.5 TO 6.0.6  48405 ET SW 6.5 - X-RAY MONITORING  48423 ET UP P&R WORKSTATION 6.0.X to 6.5 (FULL  48440 EXACTRAC UPG SOFTWARE 6.0 TO 6.5  48441 EXACTRAC UPG SOFTWARE 6.0 TO 6.5 P&R  48442 EXACTRAC UPGRADE 6.1/2 TO 6.5  48443 EXACTRAC UPG SOFTWARE 6.1/2 TO 6.5 P&R  48444 EXACTRAC UPG SOFTWARE 5.5 TO 6.5  48445 EXACTRAC UPG SOFTWARE 5.5 TO 6.5 P&R  48446 EXACTRAC UPG 6.1/2 TO 6.5 SERVICE CUSTOM  48447 EXACTRAC UPG 6.1/2 TO 6.5 SERVICE CU P&R  49926 ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR)  49927 ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR)  49931 ET 6.0 UPGRADE TO X-RAY SNAP MONITORING  49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3  49938 ET SOFTWARE UPDATE 6.0.3TO 6.0.4  49939 ET SOFTWARE UPDATE 6.0.X to 6.0.4 P&R  49971 CBCT IMPORT & ALIGNMENT SOFTWARE  49977 ET GENERATOR UPGRADE HFE/MP TO DUAL HFE  49996 ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY  49997 ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED  20849 EXACTRAC 6.X ADI LOADING LICENSE  20882A ET SW 6.5 - IR POSITIONING  20883A ET SW 6.5 - X-RAY MONITORING STANDALONE  25702 ET SW 6.2 - X-RAY MONITORING SUB.  25710B ET SW - DATA PREP REVIEW SUB.  25722 ET SW 6.2 - X-RAY MONITORING SUB. FOC  25723B ET SW - DATA PREP REVIEW SUB. FOC  48302A ET DATA PREP / REVIEW SYSTEM  48313B ET SW - DATA PREP REVIEW  48320-99 ET UPGRADE SOFTWARE 6.0 TO 6.1 SLA  48323 ET UPGRADE SOFTWARE 5.X TO 6.1 (IR+XR)  48324 ET UPGRADE SOFTWARE X.X TO 6.1 SW ONLY  48326 EXACTRAC UPGRADE 5.5 TO 6.1 BASIC  48340-99A ET SW - UPG 6.X TO 6.2 P&R FOR SER. CUS.  48343 ET UPGRADE SOFTWARE 5.X TO 6.2 (IR+XR)  48345 EXACTRAC UPG 6.X BASIC/LIMITED TO 6.2  48349 ET SW 6.0 - X-RAY POSITIONING CHINA ONLY  48355A ET SW 6.2 - X-RAY MONITORING  48362 EXACTRAC UPG 6.1.X TO 6.2 FOC  48364 EXACTRAC UPG SOFTWARE 6.X TO 6.2  48364-99 ET SW - UPG 6.X TO 6.2 FOR SER. CUS.  48364-99A ET SW - UPG 6.X TO 6.2 FOR SER. CUS.  49892 EXACTRAC 6.1 SYSTEM UPGRADE  49892A EXACTRAC 6.2 SYSTEM UPGRADE  49892B EXACTRAC 6.2 SYSTEM UPGRADE  49898 EXACTRAC 6.1 SYSTEM UPGRADE  49898B EXACTRAC 6.2 SYSTEM UPGRADE  49926A ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR)  49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR)  49927A ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR)  49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR)  49928 ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR)  49928A ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR)  49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR)  49933 ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED  49933A ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED  49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED  49934 EXACTRAC UPGRADE 5.5 TO 6.0 BASIC  49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC  49936A ET SOFTWARE UPDATE 6.0.X TO 6.0.4  49936B ET SOFTWARE UPDATE 6.0.X TO 6.0.5  49936C ET SOFTWARE UPDATE 6.0.X TO 6.0.6  49938A ET SOFTWARE UPDATE 6.0.3TO 6.0.5  49938B ET SOFTWARE UPDATE 6.0.3TO 6.0.6  49939A ET SOFTWARE UPDATE 6.0.X to 6.0.5 P&R  49964 ET SYSTEM CONTROL UNIT (1 RACK)  49964B ET SYSTEM CONTROL UNIT (1 RACK)  49973 ET DATA PREP / REVIEW SYSTEM  49973A ET DATA PREP / REVIEW SYSTEM  49973B ET DATA PREP / REVIEW SYSTEM  49996A ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY  49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY  49997A ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED  49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED  49998 ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT  49998A ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT  49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT  70359-01 EXACTRAC 6.0 IR POSITIONING SOFTWARE FOC",
      "more_code_info": ""
    }
  ]
}