{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Mansfield",
      "address_1": "15 Hampshire St",
      "reason_for_recall": "Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on GUI during ventilation",
      "address_2": "",
      "product_quantity": "9,593",
      "code_info": "Serial Numbers:  35B1300001 through 35B1300051    35B1400003 through 35B1402216     35B1500001 through 35B1502227    35B1600001 through 35B1601408    35B1700001 through 35B1702519    35B1800001 through 35B1801541    35B1400001                      35B1601182, 35B1601183, 35B1601193, 35B1601197, 35B1601242  35B1601243, 35B1601245, 35B1702479, 35B1601001, 35B1601089",
      "center_classification_date": "20181218",
      "distribution_pattern": "Worldwide Distribution - US Nationwide  Foreign:  Canada  Argentina  Chile  Japan  Hong Kong  Taiwan  Uruguay  Austria  Austria  Azerbaijan  Belgium  Bosnia And Herzegovina  Bulgaria  Croatia  Czech Republic  France  Germany  Greece  Hungary  Ireland  Israel  Italy  Kazakhstan  Kenya  Kuwait  Latvia  Lebanon  Lithuania  Netherlands  Oman  Pakistan  Poland  Portugal  Romania  Russian Federation  Saudi Arabia  Slovakia  Slovenia  South Africa  Spain  Sweden  Switzerland  Tunisia  Turkey  United Arab Emirates  Iran  United Kingdom",
      "state": "MA",
      "product_description": "Puritan Bennett 980 (PB980) ventilator series:  Puritan Bennett\" 980 Pediatric   Adult Ventilator  Puritan Bennett\" 980 Neonatal Ventilator  Puritan Bennett\" 980 Universal Ventilator    Product Usage:  The Puritan Bennett  980 Series Ventilator is designed for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb). It is suitable for service in hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilatory support using medical oxygen and compressed medical air from either an internal air compressor or external air sources to deliver oxygen concentrations of 21% to 100%. Ventilatory support can be delivered invasively or non-invasively, to patients who require the followingtypes of ventilator support:   Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasively (via mask or nasal prongs).   Assist/ Control, SIMV or Spontaneous modes of ventilation",
      "report_date": "20181226",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "COVIDIEN LLC",
      "recall_number": "Z-0497-2019",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "81167",
      "termination_date": "20210201",
      "more_code_info": "",
      "recall_initiation_date": "20180918",
      "postal_code": "02048-1113",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}