{
  "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": "Andover",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "78702",
      "recalling_firm": "Philips Electronics North  America Corporation",
      "address_1": "3000 Minuteman Rd",
      "address_2": "N/A",
      "postal_code": "01810-1032",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "1067 US customers  163 Canada, 917 International",
      "recall_number": "Z-0348-2018",
      "product_description": "ECG Out Cable  -  Heartstart MRx  M1783A/M5526A 12-pin Sync cables  All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641.  Manufactured - September 4, 2002   October 8, 2014",
      "product_quantity": "15811",
      "reason_for_recall": "Issue with ECG out cables.  When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable or ECG out cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (EFTs):    \"\tOn the HeartStart MRx and HeartStart XL, EFT noise may be misinterpreted as an R-wave.  \"\tOn the HeartStart XL+, EFT noise can disable ECG monitoring and potentially interrupt demand mode pacing*.     *Note: It is contrary to the XL+ Instructions for Use to perform demand mode pacing while using the ECG out cable or obtaining the ECG signal from a bedside monitor. The XL+ Instructions for Use includes the following warning:  When pacing in Demand Mode, the ECG cable from the patient must be directly connected to the HeartStart XL+.  If the user follows this warning, this problem cannot occur on the XL+.",
      "recall_initiation_date": "20170717",
      "center_classification_date": "20180114",
      "termination_date": "20180712",
      "report_date": "20180124",
      "code_info": "M1783A/M5526A 12-pin Sync cables    All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641"
    }
  ]
}