{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "176885",
      "product_res_number": "Z-0176-2020",
      "event_date_initiated": "2019-09-25",
      "event_date_created": "2019-10-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-03-25",
      "res_event_number": "83978",
      "product_code": "LMA",
      "product_description": "Patient Data Manager, Model/Catalogue Numbers:  \n25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY\n25100-10 - PATIENT DATA MANAGER 2.2.0 LICENSE ONLY\n25100-11 - PATIENT DATA MANAGER 2.2.1 LICENSE ONLY \n25100-12 - PATIENT DATA MANAGER 2.3 INSTALLER  \n25100-12A - PATIENT DATA MANAGER 2.3.1 INSTALLER \n25100-13 - PATIENT DATA MANAGER 2.3 LICENSE  \n25100-12B - PATIENT DATA MANAGER 2.4.0 INSTALLER \n25100-13A - PATIENT DATA MANAGER 2.4 LICENSE  \n25100-12C - PATIENT DATA MANAGER 2.5.0 INSTALLER \n25100-12D - PATIENT DATA MANAGER 2.5.1 INSTALLER \n25100-13B - PATIENT DATA MANAGER 2.5 LICENSE\nused 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.",
      "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.",
      "firm_fei_number": "3002619595",
      "recalling_firm": "Brainlab AG",
      "address_1": "Olof-palme-str. 9 9 olof-palme-str.",
      "city": "Munich",
      "country": "Germany",
      "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.",
      "root_cause_description": "Software design",
      "action": "As of September 25, 2019 for new installations or updates/upgrades to the affected SW version, the Field Safety Notice / Product Notification letter is hand delivered to the customer during installation (before clinical use) by the according Brainlab Service representative  All other consignees were notified by email on 10/04/2019.  \n\nThe letter details how the even occurs and provides instruction on how to avoid the issue until a software revision is disseminated.",
      "product_quantity": "1230 units",
      "distribution_pattern": "worldwide",
      "openfda": {
        "k_number": [
          "K020243",
          "K993599",
          "K982785",
          "K973411",
          "K980809",
          "K980873",
          "K993598",
          "K953964",
          "K993597",
          "K952485",
          "K961768",
          "K933830",
          "K924478",
          "K953942",
          "K943357",
          "K932760",
          "K894412",
          "K013631",
          "K042484",
          "K130406",
          "K896739",
          "K925799",
          "K021949",
          "K102476",
          "K874778",
          "K933632",
          "K911082",
          "K971894",
          "K980213",
          "K093809",
          "K954875",
          "K960839",
          "K091288",
          "K860777",
          "K896223",
          "K013395",
          "K022810",
          "K990066",
          "K964288",
          "K032022",
          "K011049",
          "K984409",
          "K925721",
          "K130636",
          "K890970",
          "K132183",
          "K953117",
          "K000411",
          "K890477",
          "K974619",
          "K970908",
          "K980565",
          "K974315",
          "K901423",
          "K001841",
          "K033637",
          "K850330",
          "K933129",
          "K063424",
          "K992467",
          "K984252"
        ],
        "registration_number": [
          "3009717300",
          "3008596921",
          "3015976667",
          "3039346136",
          "1316463",
          "3007766685",
          "3026970882",
          "3010461419"
        ],
        "fei_number": [
          "3009717300",
          "3008596921",
          "3015976667",
          "3039346136",
          "1316463",
          "3007766685",
          "3026970882",
          "3010461419"
        ],
        "device_name": "Digitizer, Image, Radiological",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.2030",
        "device_class": "2"
      }
    }
  ]
}