Device Recall 12Lead ECG Cable

  • Modelo / Serial
    12-lead ECG Cable with Limb Lead Attachment Part Numbers: 3302822-000-AHA; 3302822-002-AHA; 3302822-001-IEC; 3302822-003-IEC.  Precordial Lead Attachment Part Numbers: 3302823-000-AHA and 3302823-001-IEC.  No Serial numbers for 12-Lead ECG Cable.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution--USA (nationwide) including Puerto Rico and countries of Australia, Brazil, Chile, Germany, Hong Kong, Mexico, The Netherlands, and New Caledonia.
  • Descripción del producto
    12-lead ECG Cable Assembly contains the following cable and attachments: || Main Cable with Limb Leads: The main cable includes the proximal connector which attaches to the monitor and four incorporated limb lead wires that terminate with ECG electrode snaps. All signals travel through this cable for cardiac monitoring and for 12-lead ECGs. || Precordial Lead Attachment: The precordial lead attachment includes the precordial connector which attaches to the main cable with six precordial leads (also terminated with ECG electrode snaps). || This attachment is used when a 12-lead ECG is needed. The main cable includes a cover over the connector for the precordial lead attachment to protect it from contaminants if the precordial lead attachment is not || connected. || This 12-lead ECG Cable Assembly is designed for use in the Pre-hospital and hospital environment. The 12-lead ECG cables are currently available for the LIFEPAK 12 Defibrillator/Monitor and LIFEPAK 15 Monitor/Defibrillator. The 12-lead electrocardiogram is used to identify, diagnose and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute ST elevation myocardial infarction (STEMI). Documentation of transient or intermittent arrhythmias and other electrophysiologic events that occur in the prehospital setting can assist in diagnosis and treatment decisions in the Emergency Department.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Physio Control, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • Empresa matriz del fabricante (2017)
  • Source