Events

Retiro De Equipo (Recall) de Device Recall EP4 Stimulator

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 St. Jude Medical.

¿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
    51681
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1422-2009
  • Fecha de inicio del evento
    2009-03-23
  • Fecha de publicación del evento
    2009-06-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-01-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80957
  • 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
    External Programmable Pacemaker Pulse Generator - Product Code JOQ
  • Causa
    Non-compliance with iec standard 60601-1 clause 57.6 relative to fusing of ac input line. the neutral line is not fused. the hot line in fused. clause 57.6 calls for both lines to be fused.
  • Acción
    All foreign customers were sent Urgent Product Safety Information letters on March 23, 2009. Letters described units affected, the reason for action, and the actions to take to eliminate risk. It is recommended that the information in the letter be circulated to all users, risk managers and the biomedical engineering department responsible for maintaining and inspecting electrical equipment located within their institution. The letter also stated that a SJM representative will be in touch to perform the EP-4 Stimulator fuse modification. Customers are to complete and return the attachment.

Device

Device Recall EP4 Stimulator
  • Modelo / Serial
    Systems Part Numbers: EP-4I-2-110; EP-4I-2-220; EP-4I-4-110; EP-4-220: WM-01M-241; WM-01M-560; WM-01M-1200; WM-02M-241; WM-02M-560; and WM-02M-1200.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution.
  • Descripción del producto
    EP-4 Computerized Cardiac Stimulator; SJM Part Numbers: 09-1527-0000 / 09-1527-0002; || EP MedSystems, Inc. || 575 Route 73 North, Units D, West Berlin, NJ 08091. || Indicated for use during clinical electrophysiology procedures.
  • Manufacturer
    St. Jude Medical

Manufacturer

St. Jude Medical
  • Dirección del fabricante
    St. Jude Medical, 575 Route 73 North, Bldg D, Cooper Run Executive Park, West Berlin NJ 08091
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA