{
  "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": "Waukesha",
      "state": "WI",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "82937",
      "recalling_firm": "GE Healthcare, LLC",
      "address_1": "3000 N Grandview Blvd",
      "address_2": "N/A",
      "postal_code": "53188-1615",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: US (nationwide)  including Puerto Rico, and countries of: Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malta, Mauritius, Mexico, Moldova, Morocco, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Palestine (state of), Panama, Poland, Qatar, Republic of Serbia, Romania, Russia, Saudia Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad and Tobago, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.",
      "recall_number": "Z-1878-2019",
      "product_description": "Leadwire sets with snap ends:  REF/Catalog Number\tDescription  2106381-001\tECG Leadwire set, 5-lead, snap, AHA, 74 cm/ 29 in  2106381-002\tECG Leadwire set, 5-lead, snap, AHA, 130 cm/ 51 in  2106381-003\tECG Leadwire set, 5-lead, snap, IEC, 74 cm/ 29 in  2106381-004\tECG Leadwire set, 5-lead, snap, IEC, 130 cm/ 51 in  2106381-005\tECG Leadwire set, 5-lead, snap, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in  2106383-001\tECG Leadwire set, 5-lead, grouped, snap, AHA, 74 cm/ 29 in  2106383-002\tECG Leadwire set, 5-lead, grouped, snap, AHA, 130 cm/ 51 in  2106383-003\tECG Leadwire set, 5-lead, grouped, snap, IEC, 74 cm/ 29 in  2106383-004\tECG Leadwire set, 5-lead, grouped, snap, IEC, 130 cm/ 51 in  2106383-005\tECG Leadwire set, 5-lead, grouped, snap, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in  2106383-006\tECG Leadwire set, 5-lead, grouped, snap, IEC, mix 74 cm/ 29 in, 130 cm/ 51 in  2106385-001\tECG Leadwire set, 3-lead, snap, AHA, 74 cm/ 29 in  2106385-002\tECG LEADWIRE SET, 3-LD GROUPED, SNAP, AHA, 130 CM/ 51 IN  2106385-003\tECG LEADWIRE SET, 3-LD GROUPED, SNAP, IEC, 74 CM/ 29 IN  2106385-004\tECG LEADWIRE SET, 3-LD GROUPED, SNAP, IEC, 130 CM/ 51 IN  2106394-003\tECG Leadwire set, 5-lead V2-6, snap, AHA, 74 cm/ 29 in  2106395-001\tECG Leadwire set, 6-lead, grouped, snap, AHA, 74 cm/ 29 in  2106396-001\tECG Leadwire set, 6-lead, grouped, snap, IEC, 74 cm/ 29 in  2106396-002\tECG Leadwire set, 6-lead, grouped, snap, IEC, 130 cm/ 51 in    The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets with ECG trunk cable or telemetry transmitter.",
      "product_quantity": "58,045 units (31,108 US; 26937 OUS) in total",
      "reason_for_recall": "ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.",
      "recall_initiation_date": "20190510",
      "center_classification_date": "20190625",
      "termination_date": "20240524",
      "report_date": "20190703",
      "code_info": "product does not have lot or serial codes  REF/Catalog Number GTIN/UDI  2106381-001 00840682139953  2106381-002 00840682140201  2106381-003 none  2106381-004  none  2106381-005 00840682139854  2106383-001 00840682140126  2106383-002 00840682140096  2106383-003 none  2106383-004 none  2106383-005 00840682140034  2106385-001 00840682139588  2106385-002 00840682140119  2106385-003 none  2106385-004 none  2106394-003 00840682140102  2106395-001 00840682139649  2106396-001 none  2106396-002 none"
    }
  ]
}