{
  "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,
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  "results": [
    {
      "cfres_id": "36935",
      "product_res_number": "Z-0713-05",
      "event_date_initiated": "2005-01-13",
      "event_date_posted": "2005-04-19",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-03-13",
      "res_event_number": "30986",
      "product_code": "JOQ",
      "k_numbers": [
        "K991293"
      ],
      "product_description": "Bloom DTU-215-B Programmable Stimulator",
      "code_info": "All Bloom DTU-215-B Programmable Stimulators.",
      "firm_fei_number": "1418957",
      "recalling_firm": "Fischer Imaging Corporation",
      "address_1": "12300 Grant St",
      "city": "Denver",
      "state": "CO",
      "postal_code": "80241-3120",
      "additional_info_contact": "Tom Gibson\n303-254-2525",
      "reason_for_recall": "Possibility that after a loss of power or brown-out, the device may transmit unintended stimulation to patients.",
      "root_cause_description": "Other",
      "action": "Customers were notified by letter on 01/13/05.",
      "product_quantity": "712 units",
      "distribution_pattern": "Nationwide.  Foreign distribution: Canada, Australia, Ireland, Italy, Japan, Malaysia, Switzerland, Netherlands, United Kingdom.",
      "openfda": {
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        "device_name": "Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1750",
        "device_class": "2"
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}