{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Munich",
      "state": "",
      "country": "Germany",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "83978",
      "recalling_firm": "Brainlab AG",
      "address_1": "Olof-palme-str. 9",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Visit",
      "distribution_pattern": "worldwide",
      "recall_number": "Z-0176-2020",
      "product_description": "Patient Data Manager, Model/Catalogue Numbers:    25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY  25100-10 - PATIENT DATA MANAGER 2.2.0 LICENSE ONLY  25100-11 - PATIENT DATA MANAGER 2.2.1 LICENSE ONLY   25100-12 - PATIENT DATA MANAGER 2.3 INSTALLER    25100-12A - PATIENT DATA MANAGER 2.3.1 INSTALLER   25100-13 - PATIENT DATA MANAGER 2.3 LICENSE    25100-12B - PATIENT DATA MANAGER 2.4.0 INSTALLER   25100-13A - PATIENT DATA MANAGER 2.4 LICENSE    25100-12C - PATIENT DATA MANAGER 2.5.0 INSTALLER   25100-12D - PATIENT DATA MANAGER 2.5.1 INSTALLER   25100-13B - PATIENT DATA MANAGER 2.5 LICENSE  used in combination with iPlan CMF/Cranial/ENT/Spine 3.0.5, 3.0.6. Product Usage: Patient Data Manager is intended to load patient data from and export patient data to connected network locations (like file shares and PACS) and removable media. Furthermore, the software is intended to start other applications (like Brainlab planning and navigation applications) and to route applications and connected video sources to displays attached to the system that are running Patient Data Manager. The software is also intended to connect two Brainlab systems to each other via network.",
      "product_quantity": "1230 units",
      "reason_for_recall": "The Brainlab Patient Data Manager software (PDM) in combination with the Brainlab iPlan CMF/Cranial/ENT/Spine software 2.1.1, 2.2.0, 2.2.1, 2.3.0, 2.3.1, 2.4.0, 2.5.0, 2.5.1 (if used in combination with iPlan CMF/Cranial/ENT/Spine 3.0.5, 3.0.6) that may lead to shifts applied to segmentation objects in iPlan being not reflected when exported into DICOM under specific circumstances.",
      "recall_initiation_date": "20190925",
      "center_classification_date": "20191023",
      "termination_date": "20240325",
      "report_date": "20191030",
      "code_info": "Patient Data Manager versions   2.1.1 no GTIN  2.2.0 no GTIN  2.2.1 no GTIN  2.3.0, GTIN 04056481006662  2.3.1, GTIN 04056481132453   2.4.0, GTIN 04056481138615   2.5.0, GTIN 04056481140502  2.5.1, GTIN 04056481140502    versions 2.1.1, 2.2.0, 2.2.1, 2.3.0, 2.3.1, 2.4.0, 2.5.0, 2.5.1.",
      "more_code_info": ""
    }
  ]
}