{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63614",
      "recalling_firm": "Mindray DS USA, Inc. d.b.a. Mindray North America",
      "address_1": "800 MacArthur Blvd.",
      "address_2": "N/A",
      "postal_code": "07430",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution-USA (nationwide) including the states of WA, IL, FL, MN, SC, NV, MI, TN, PA, LA, NE, TX, and IA.",
      "recall_number": "Z-0513-2013",
      "product_description": "DPM 6/7 Patient Monitor  Manufactured in China for :   Mindray DS USA, Inc.  800 MacArthur Blvd.  Mahwah, NJ 07430 USA.    Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection, ST Segment analysis, heart rate (HR) , respiration rate (RESP), temperature (TEMP), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG),impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM).",
      "product_quantity": "124 units",
      "reason_for_recall": "There is an issue with the DPM 6 and DPM 7 monitors where the following features may be unavailable : Full Disclosure, Drug, Hemodynamic Calculations, Renal Calculations, Oxygenation Calculations, and Ventilation Calculations.",
      "recall_initiation_date": "20100811",
      "center_classification_date": "20121211",
      "termination_date": "20130802",
      "report_date": "20121219",
      "code_info": "K092449    DPM 6- p/n 6802F-PA00001    DPM 7 - p/n 6800F-PA00001"
    }
  ]
}