{
  "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,
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  },
  "results": [
    {
      "cfres_id": "26179",
      "product_res_number": "Z-0702-03",
      "event_date_initiated": "2003-02-21",
      "event_date_posted": "2003-04-01",
      "recall_status": "Terminated",
      "event_date_terminated": "2003-09-08",
      "res_event_number": "25629",
      "product_code": "LWS",
      "pma_numbers": [
        "P000009/S4"
      ],
      "product_description": "Tachos DR - Atrial TX Implantable Cardioverter Defibrillators",
      "code_info": "Model No. 122 499 Serial Nos. 78010961, 78012035, 78012076, 78012077,  78012083, 78012090-78012092, 78012103-78012105, 78012109-78012111, 78012117-78012120, 78012122-78012125,78012127, 78012132, 78012163, 78012197, 78012236, 78012292, 78012296, 78012298-78012302, 78012352, 78012354, 78012355, 78012366, 78012369, 78012374, 78012386, 78012413, 78012415, 78012564, 78012652",
      "firm_fei_number": "1028232",
      "recalling_firm": "Biotronik Inc",
      "address_1": "6024 Jean Road",
      "city": "Lake Oswego",
      "state": "OR",
      "postal_code": "97035-5369",
      "additional_info_contact": "Jon Brumbaugh\n888-345-0374",
      "reason_for_recall": "Potential for battery to delivery less than full amount of energy",
      "root_cause_description": "Other",
      "action": "The firm issued an 'URGENT - VOLUNTARY MEDICAL DEVICE' recall letter dated 2/21/03 to the physicians.  This letter explains the issue and recommends scheduling an immediate follow-up with the patients.  \n\nThe letter describes conditions under which the patient should be monitored on a weekly basis (versus every 3 months), and under which conditions the device should be explanted.",
      "product_quantity": "49 devices (45 still implanted)",
      "distribution_pattern": "The firm distributed devices to doctors located throughout the U.S.  \n\nThere is no international distribution from this firm.",
      "openfda": {
        "pma_number": [
          "P010031",
          "P900061",
          "P980016",
          "P880086",
          "P940008",
          "P030035",
          "P970024",
          "P980050",
          "P010012",
          "P830060",
          "P970013",
          "P110042",
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          "P910073",
          "P890061",
          "P910077",
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          "P950022",
          "P960040",
          "P920015",
          "P980023",
          "P940024",
          "P220012"
        ],
        "device_name": "Implantable Cardioverter Defibrillator (Non-Crt)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
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}