Events

Retiro De Equipo (Recall) de Device Recall Zoll AED Plus

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 ZOLL Medical Corporation, World Wide Headquarters.

¿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
    51053
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1206-2009
  • Fecha de inicio del evento
    2009-02-12
  • Fecha de publicación del evento
    2009-04-01
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=78412
  • 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
    automated external defibrillator - Product Code MKJ
  • Causa
    Device fails to discharge the defibrillation energy.
  • Acción
    On 3/31/09, the firm revised their recall strategy and required all users to a perform a "Mandatory Upgrade" software The software upgrade allows all potentially affected devices to monitor battery charging performance through periodic self-testing. If defective batteries are detected at any time prior to the recommended maximum of five years, users are prompted by the device to install fresh batteries. Frim issued Press Release on April 2, 2009. In the first notification Zoll notified customers by letter on 2/12/09 via certified mail. Customers instructed to replace device batteries every three years. In lieu of replacing batteries every three years, customers will also have the choice to update their devices with software that will monitor batteries for the identified defect. ZOLL will be send email notification to all consignees who have provided an email address as part of their contact information. ZOLL will also be publishing information of the notification on industry magazines. http://www.zollaedplusbatteryhelp.com/

Device

Device Recall Zoll AED Plus

Manufacturer

ZOLL Medical Corporation, World Wide Headquarters
  • Dirección del fabricante
    ZOLL Medical Corporation, World Wide Headquarters, 269 Mill Rd, Chelmsford MA 01824
  • Empresa matriz del fabricante (2017)
    Asahi Kasei Corp.
  • Source
    USFDA