{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "49391",
      "product_res_number": "Z-0288-2007",
      "event_date_initiated": "2006-11-07",
      "event_date_posted": "2006-12-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-07-21",
      "res_event_number": "36811",
      "product_code": "CXT",
      "k_numbers": [
        "K042744"
      ],
      "product_description": "OptiVantage DH Power Injection System.",
      "code_info": "All codes.",
      "firm_fei_number": "1518293",
      "recalling_firm": "Mallinckrodt Inc",
      "address_1": "2111 E Galbraith Rd",
      "city": "Cincinnati",
      "state": "OH",
      "postal_code": "45237-1624",
      "additional_info_contact": "Dale Moore\n513-948-5771",
      "reason_for_recall": "The flow rate programmed on the console may be changed without automatically updating the flow rate programmed on the power head. The injector will always inject in accordance with the parameters shown on the power head. If this lack of synchronization occurs and is not noticed by the clinican, contrast would be injected at a higher or lower flow rate than desired.",
      "root_cause_description": "Other",
      "action": "The recalling firm sent a letter dated 11/7/2006 to all consignees.",
      "product_quantity": "1348 devices.",
      "distribution_pattern": "Worldwide distribution ---- including USA and countries of Australia, Belgium, Brazil, Canada, Chile, Columbia, Denmark, Mexico, Panama, Puerto Rico, Singapore and South Africa.",
      "openfda": {}
    }
  ]
}