Events

Retiro De Equipo (Recall) de Device Recall Battery Pack

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 Respironics, 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
    29333
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1220-04
  • Fecha de inicio del evento
    2004-06-04
  • Fecha de publicación del evento
    2004-07-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-01-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33562
  • 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
    Monitor, Breathing Frequency - Product Code BZQ
  • Causa
    Recalling firm received a product complaint from a customer that the lead wire from model 915 battery was not connected.
  • Acción
    The recalling firm sent a recall letter to their direct accounts, which include parents and vendors regarding the problem associated with the battery packs. The recall letter advised their customers to check their inventory and if the battery pack is one of the affected recalled product to immediately contact their Customer Service Department. to arrange for replacement battery packs.

Device

Device Recall Battery Pack
  • Modelo / Serial
    Model Number 915 Manufacturing Lot Number 45-03
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The recalled product was distributed nationwide and internationally to the folllowing states: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WI, WV . In regards to foreign accounts, the product was distributed to Canada and British Columbia.
  • Descripción del producto
    Battery Pack Respironics Model 915 for use in the 900 Series SmartMonitor and the 900 Series Pulse Oximeter.
  • Manufacturer
    Respironics, Inc.

Manufacturer

Respironics, Inc.
  • Dirección del fabricante
    Respironics, Inc., 1010 Murry Ridge Ln, Murrysville PA 15668
  • Source
    USFDA