Retiro De Equipo (Recall) de LifeStar ACT III Platinum Sensor

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Lifewatch Services Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    59990
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0207-2012
  • Fecha de publicación del evento
    2011-11-17
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2012-05-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Transmitters and receivers, electrocardiograph, telephone - Product Code DXH
  • Causa
    Lifewatch received complaints of minor shocks and burns during use of the lifestar act systems with shorts in the leads.
  • Acción
    The firm, LifeWatch, sent an " Urgent Device Recall" letter dated September 27, 2011 to the affected customers. The letter describes the product, problem and action to be taken. The customers were instructed to immediately refrain from providing these devices to their customers; stop using the affected sensors, return their entire kit in the pre-paid mailer, and use the new device kit included with the recall letter. In addition, the letter informed the users that the replacement device has upgraded software and firmware that allows for detection of shorts in the cable, and if detected, cuts off current flow to the patient to prevent minor shocks and burns. If you have any questions, please call (847) 813-4258.

Device

  • Modelo / Serial
    Model FG-00084, all serial numbers with firmware REV 10.4
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution.
  • Descripción del producto
    LifeStar ACT III Platinum Sensor Ambulatory Cardiac Telemetry; an automatically activated system with a high performance triple channel EKG, office hookup and auto send/auto detect that requires no patient intervention to either capture or transmit an arrhythmia when it occurs; Manufactured by Card Guard, 2 Pekeris St, Rehovot, 76100, Israel; Model FG-00084 || LifeStar ACT provides critical ECG information by capturing the onset and termination/escape of an arrhythmia to assist in correctly identifying and treating the patient. Patients are monitored for up to 30 days and all of the data is available at the request of the physician during the service period and for 7 days following the end of service. The ACT III will provide more sensitive data for initial or early detection of arrhythmia in patients that have minimal or atypical symptoms.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Lifewatch Services Inc, 10255 W Higgins Rd, O'Hare International Center II, Rosemont IL 60018-5606
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA