{
  "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": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81084",
      "recalling_firm": "Mindray DS USA, Inc. dba Mindray North America",
      "address_1": "800 Macarthur Blvd",
      "address_2": "N/A",
      "postal_code": "07430-2001",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed to accounts in CA, CO, FL, MA, NY, PA, PR, TX, and WV.",
      "recall_number": "Z-0170-2019",
      "product_description": "Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00",
      "product_quantity": "5",
      "reason_for_recall": "The firm has identified performance anomalies with the device caused when more than 64 TD60 telemetry transmitters have been connected to a central station. The anomaly causes some ECG waveforms to appear as a flat line at the centralized viewing station and will manifest if more than 64 TD60 transmitters have been connected to a given central station server. Each central station supports only 32 transmitters at a time. For the issue to manifest, the BeneVision DMS needs to be configured to use flexible device assignment, have more than 64 TD60 transmitters, and the workflow must allow 64 TD60s to move around  between multiple central stations in the same care area.",
      "recall_initiation_date": "20180830",
      "center_classification_date": "20181017",
      "termination_date": "20181220",
      "report_date": "20181024",
      "code_info": "This potential issue affects BeneVision DMS with software version 03.01.00  to 03.03.00"
    }
  ]
}