Events

Retiro De Equipo (Recall) de Medtronic/Physio Control Transparent Defibrillation Electrodes

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 TZ Medical 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
    65120
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1438-2013
  • Fecha de inicio del evento
    2013-04-30
  • Fecha de publicación del evento
    2013-05-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117920
  • 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
    Pacemaker, cardiac, external transcutaneous (non-invasive) - Product Code DRO
  • Causa
    Tz medical inc is recalling its p-211-m1 and p-214-m1 medtronic / physio control compatible transparent defibrillation electrodes because it may contain a defective white wire on the connector assembly. if a failure were to occur, the end user would be able to identify the failure by inspecting the white wire 1/4 inch from the gray medtronic / physio adapter. the consignees will notice discolor.
  • Acción
    TZ Medical Inc. started notifying their customers by telephone on April 30, 2013. The firm followed up with an Urgent: Medical Device Recall notification letter dated May 14, 2013, to their consignees. TZ Medical Inc., Representatives have will contact all affected customers and arrange for the replacement of the effected product in stock with inspected product. For any questions about this recall, please fax to 503-639-0239.

Device

Medtronic/Physio Control Transparent Defibrillation Electrodes
  • Modelo / Serial
    Model P-211-M1 Lot numbers:  Y081712-17; Y081712-18; Y081712-19; Y081712-20; Y112612-08; Y112612-09; Y112612-10; Y112612-11; Y112612-12; Y112612-13; and Y020113-07.  Model P-214-M1 Lot numbers:  Y081712-04; Y112612-24; Y112612-23; and Y031913-10.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution - USA (nationwide) and Chile.
  • Descripción del producto
    adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. || Product Usage: || Used by trained professionals in hospitals, doctors offices, and Emergency Medical Services for adult low-energy defibrillation, transcutaneous pacing, cardioversion and monitoring.
  • Manufacturer
    TZ Medical Inc.

Manufacturer

TZ Medical Inc.
  • Dirección del fabricante
    TZ Medical Inc., 17750 SW Upper Boones Ferry Rd Ste 150, Portland OR 97224-7086
  • Empresa matriz del fabricante (2017)
    TZ Medical Inc.
  • Source
    USFDA