{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Milwaukee",
      "state": "WI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85297",
      "recalling_firm": "WELCH ALLYN, INC/MORTARA",
      "address_1": "7865 N 86th St",
      "address_2": "N/A",
      "postal_code": "53224-3431",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, ON, OR, PA, PR, RI, SC, SD, TN,UT, VA, VT, WA, WI, WV and WY.",
      "recall_number": "Z-1815-2020",
      "product_description": "S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF ECG SNAP ENDS AHA GRAY, CABLE 10 WIRE LF ECG SNAP ENDS IEC GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS AHA GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS IEC GRAY.     The S4 mobile monitor provides a means to acquire and transmit simultaneous ECG and SpO2 data to a Surveyor Central Station monitoring system while allowing the patient to be ambulatory within the range of the WiFi network.",
      "product_quantity": "78,521 units total",
      "reason_for_recall": "Impacted Welch Allyn products may not meet the  Defibrillation Withstand  requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.",
      "recall_initiation_date": "20200318",
      "center_classification_date": "20200429",
      "termination_date": "20260209",
      "report_date": "20200506",
      "code_info": "Model Numbers: S4-Q-ASX-XXX, S4-Q-AXX-XXX, S4-P-A, 9293-061-50, 9293-061-51, 9293-061-52, 9293-061-53."
    }
  ]
}