Events

Retiro De Equipo (Recall) de Device Recall TriaDyne Proventa Critical Care Therapy System

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 Arjo Hospital Equipment AB.

¿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
    69970
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1218-2015
  • Fecha de inicio del evento
    2014-12-03
  • Fecha de publicación del evento
    2015-02-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-10-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133851
  • 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
    Bed, patient rotation, powered - Product Code IKZ
  • Causa
    The recalled devices labeling and instructions for use contain unapproved medical claims.
  • Acción
    Devices in the rental fleet will be delivered to the customer with revised documents including the updated information. The customers who purchased the devices will be notified of the recall via letter sent by registered mail. The field correction notice will include a recall letter, response form, and updated labeling.

Device

Device Recall TriaDyne Proventa Critical Care Therapy System
  • Modelo / Serial
    SERIAL NUMBERS: 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 TDDK00331 TDDK00349 TDGK00055 TDDK00343 TDBK00152 TDBK00143 TDDK00262 TDDK00288 TDDK00338 TDGK00131 TDGK00075 TDBK00140 TDDK00133 TDGK00171 TDBK00260 TDBK00287 TDDK00180 TDDK00143 TDGK00009 TDGK00086 TDBK00362 TDDK00239 TDBK00330 TDBK00057 TDBK00021 TDBK00378 TDDK00216 TDDK00136 TDBK00376 TDDK00342 TDBK00038 TDDK00329 TDBK00308 TDBK00289 TDBK00039 TDDK00160 TDGK00015 TDGK00034 TDGK00065 TDGK00156 TDBK00154 TDGK00165 TDGK00044 TDBK00126 TDGK00067 TDGK00151 TDDK00105 TDGK00161 TDGK00149 TDBK00298 TDDK00178 TDDK00251
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution. US nationwide, Germany, Austria, France, Italy, India, EU, Mexico, Switzerland, Canada, Saudi Arabia, Kuwait, Middle East, China, Japan, and Qatar.
  • Descripción del producto
    TriaDyne Proventa Critical Care Therapy System. || The TriaDyne Proventa Critical Care Therapy System provides a comprehensive system of pulmonary and skin care therapies for the critically ill, immobilized patient.
  • Manufacturer
    Arjo Hospital Equipment AB

Manufacturer

Arjo Hospital Equipment AB
  • Dirección del fabricante
    Arjo Hospital Equipment AB, HANS MICHELSENSGATAN 10, Malm¿ Sweden
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA