Events

Retiro De Equipo (Recall) de Device Recall Power circuit board assembly kits

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 Cardinal Health 203, 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
    46850
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1469-2008
  • Fecha de inicio del evento
    2008-02-22
  • Fecha de publicación del evento
    2008-08-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68499
  • 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
    Assembly kit - Product Code CBK
  • Causa
    The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver.
  • Acción
    An Urgent Medical Device Recall letter dated February 22, 2008 was sent to ventilator consignees/owners and distributors. The letter describes the issue, identifies the affected devices, states that the devices will be corrected by Cardinal Health and provides direction to verify ventilator operation and audible alarm function daily. Service Centers were provided information to identify affected printed circuit board assembly replacement kits' lot numbers and asked to return them. An "Update" was mailed 03/04/2008 to identify additional ventilator serial numbers that also need correction.

Device

Device Recall Power circuit board assembly kits
  • Modelo / Serial
    Lot number: PWRMK0325902, PWRMK0407201, PWRMK0420105, PWRMK0436501, PWRMK0501101, PWRMK0504603, PWRMK0505402, PWRMK0506602, PWRMK0510303, PWRMK0510804, PWRMK0512201, PWRMK0512303, PWRMK0514313, PWRMK0515201, PWRMK0515701, PWRMK0517802, PWRMK0518701, PWRMK0526503
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- USA including Puerto Rico and countries of Algeria, Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, China Peoples Republic, Colombia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Malaysia, Mexico, New Zealand, Norway, Panama, Paraguay, Philippines, Portugal, Saudi Arabia, Serbia & Montenegro, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam, and West Indies.
  • Descripción del producto
    Replacement Kit, Power PCBA with Memory PCBA. REF 14425. || Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA.
  • Manufacturer
    Cardinal Health 203, Inc

Manufacturer

Cardinal Health 203, Inc
  • Dirección del fabricante
    Cardinal Health 203, Inc, 17400 Medina Rd Ste 100, Minneapolis MN 55447-1341
  • Empresa matriz del fabricante (2017)
    Cardinal Health
  • Source
    USFDA