{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Telford",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80209",
      "recalling_firm": "Draeger Medical, Inc.",
      "address_1": "3135 Quarry Rd",
      "address_2": "N/A",
      "postal_code": "18969-1042",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide Distribution - Healthcare facilities in AK, AL, AZ, CA, CO, FL, GA, IA, IL, IN, MA, MD, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, WA, WI, and WV.",
      "recall_number": "Z-2254-2018",
      "product_description": "Perseus A500 Anesthesia Machine; Cat. no. MK06000    Product V    Product Usage:  Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressuresupported spontaneous breathing, and spontaneous breathing. Perseus is equipped with airway monitoring, gas measurement and device monitoring, O2 insufflation, and an anesthetic gas receiving system. Anesthesia is achieved through a mixture of pure oxygen and Air (medical compressed air) or pure oxygen and nitrous oxide, with the addition of volatile anesthetic agents. Ventilation is accomplished on the patient through a laryngeal mask airway, a full-face mask, or an endotracheal tube. The integrated breathing system can be used with partial rebreathing (low-flow or minimum-flow). A non-rebreathing system such as the Kuhn or Medec Water System may be used at the external fresh-gas outlet (optional). Perseus is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions.",
      "product_quantity": "33",
      "reason_for_recall": "The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result  in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.",
      "recall_initiation_date": "20180524",
      "center_classification_date": "20180619",
      "termination_date": "20200512",
      "report_date": "20180627",
      "code_info": "ASKM-0197  ASKN-0006  ASKN-0007  ASKN-0008  ASKN-0009  ASKN-0013  ASKN-0014  ASKN-0015  ASKN-0021  ASKN-0026  ASKN-0027  ASKN-0028  ASKN-0029  ASKN-0030  ASKN-0031  ASKN-0034  ASKN-0035  ASKN-0036  ASKN-0037  ASKN-0038  ASKN-0039  ASKN-0040  ASKN-0042  ASKN-0045  ASKN-0046  ASKN-0048  ASKN-0049  ASKN-0050  ASKN-0053  ASKN-0054  ASKN-0055  ASLA-0009  ASLA-0010"
    }
  ]
}