{
  "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-2250-2018",
      "product_description": "Fabius GS Premium Anesthesia Machine; Cat. no. 8607000    Product Usage:  Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series machines are equipped with a compact breathing system; providing fresh gas decoupling, PEEP, and pressure limitation. The following ventilation options are available: Volume Controlled Ventilation Pressure Controlled Ventilation Pressure Support (Optional) SIMV/PS (Optional) Manual Ventilation Spontaneous Breathing Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2). As per IEC 60601-2-13 (Anesthetic Workstations and their Modules-Particular Requirements), additional monitoring of the concentrations of CO2 and anesthetic agent is required when the machine is in use. IEC 60601-2-13:2003 requires that a manual ventilation bag must be available for emergency use. Fresh gas enrichment is provided by the Dr¿ger Vapor anesthetic vaporizer. Fabius MRI can also be used in MRI scanner rooms with magnets 1.5 tesla and 3 tesla at a fringe field strength of 40 mtesla or less",
      "product_quantity": "62",
      "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-0102 ASKM-0220  ASKM-0103 ASKM-0221  ASKM-0124 ASKM-0222  ASKM-0125 ASKM-0223  ASKM-0129 ASKM-0224  ASKM-0132 ASKM-0229  ASKM-0133 ASKN-0061  ASKM-0134 ASKN-0090  ASKM-0135 ASLA-0035  ASKM-0136 ASLA-0046  ASKM-0137 ASLA-0047  ASKM-0138 ASLA-0048  ASKM-0139 ASLA-0049  ASKM-0189 ASLA-0050  ASKM-0190 ASLA-0053  ASKM-0191 ASLA-0070  ASKM-0192 ASLA-0071  ASKM-0193 ASLA-0072  ASKM-0194 ASLA-0073  ASKM-0195 ASLA-0074  ASKM-0198 ASLA-0075  ASKM-0199 ASLA-0129  ASKM-0200 ASLA-0131  ASKM-0201 ASLA-0133  ASKM-0202 ASLA-0140  ASKM-0204 ASLA-0141  ASKM-0205 ASLA-0159  ASKM-0207 ASLA-0199  ASKM-0208 ASLA-0200  ASKM-0215 ASLA-0201  ASKM-0219 ASLA-0218"
    }
  ]
}