{
  "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,
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  "results": [
    {
      "country": "United States",
      "city": "Sylmar",
      "address_1": "15900 Valley View Ct",
      "reason_for_recall": "New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.",
      "address_2": "",
      "product_quantity": "495,011 units (391,093 in US)",
      "code_info": "Model EX1100 - GTIN 05414734504782 and Model EX1150 - GTIN 05414734404334",
      "center_classification_date": "20171019",
      "distribution_pattern": "Worldwide Distribution",
      "state": "CA",
      "product_description": "Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W.  The Merlin@home Transmitters are a component of St. Jude Medicals (SJM) Remote Care System.  These Merlin@home transmitters are used to retrieve information from the SJM implantable medical device (IMD) using RF telemetry.  The data is then sent back to the Merlin.net Patient Care Network through a built-in modem or, alternatively, through a USB cellular adapter or a USB based Broadband Kit.  The transmitted data enables clinicians to remotely monitor a patients IMD using a secure, encrypted, password-protected web site, thus reducing the number of in-clinic visits a patient needs to make to their physician.  The transmitter monitors the patients device daily between scheduled follow-ups and can alert a clinician if it detects anything out of the norm.",
      "report_date": "20171025",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "St Jude Medical Inc.",
      "recall_number": "Z-0033-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "78093",
      "termination_date": "20200708",
      "more_code_info": "",
      "recall_initiation_date": "20170828",
      "postal_code": "91342-3577",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}