{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "195688",
      "product_res_number": "Z-1775-2022",
      "event_date_initiated": "2022-08-19",
      "event_date_posted": "2022-09-22",
      "recall_status": "Open, Classified",
      "res_event_number": "90766",
      "product_code": "QOS",
      "product_description": "Puritan Bennett 560 Ventilator, PB560, CFN 4096600",
      "code_info": "UDI-DI:\n10884521196377\n\nU.S. Serial Numbers: \n40966N7229\n40966N7231\n40966N7334\n40966N7335\n40966N7340",
      "firm_fei_number": "3002807850",
      "recalling_firm": "Covidien Llc",
      "address_1": "15 Hampshire St",
      "city": "Mansfield",
      "state": "MA",
      "postal_code": "02048-1113",
      "additional_info_contact": "Technical Support\n800-255-6774",
      "reason_for_recall": "Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due to loss of gas supply caused by manufacturing error of specific turbine components.",
      "root_cause_description": "Process control",
      "action": "Consignees were notified by letter delivered beginning August 19, 2022. Medtronic is advising that continued use of PB560 ventilators is appropriate when the actions listed in the recall letter are taken into consideration, unless this continued use is inconsistent with facility internal policies and procedures.\n\nAll affected units require turbine replacement. Customers should contact Medtronic Service at 1-800-255-6774 to arrange for required service to\nreplace the affected ventilator turbine component.\n\nIf you have any questions regarding this communication, please contact your Medtronic representative or Technical Service at 1-800-255-6774.",
      "product_quantity": "5 US",
      "distribution_pattern": "Domestic distribution to one customer in Washington, D.C. Foreign distribution worldwide.",
      "openfda": {
        "device_name": "Continuous Ventilator",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N"
      }
    }
  ]
}