Events

Retiro De Equipo (Recall) de Welch Allyn Vital Signs Monitor 5300 Series 300 || Part numbers 007-0098-00 through 007-0159-00

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 Welch Allyn Protocol, 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
    29233
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1333-04
  • Fecha de inicio del evento
    2004-06-08
  • Fecha de publicación del evento
    2004-08-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-06-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33369
  • 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
    Oximeter - Product Code DQA
  • Causa
    Potential speaker failure could result in absence of audible annunciation of pulse tones, patient alarms and equipment alerts.
  • Acción
    The firm contacted their customers and their distributors customers via letters dated June 8, 2004 through July 9, 2004. The letters instruct their customers to verify speaker functionality. If the customers do not hear two quick beeps or there is static then they have a faulty speaker. The letters instruct them to stop using the monitor and contact Welch Allyn to have the monitor repaired. If the monitor continues to emit two quick beeps their customers are to contact Welch Allyn to have the monitor repaired as soon as it is convenient. The customers are to verify the two beeps prior to each use. The letter dated June 8, 2004 went to only a couple of direct customers. The remaining letters dated June 14, 2004, June 23, 2004, June 30, 2004 and July 9, 2004 went to direct customers, distributors and distributors'' end user customers.

Device

Welch Allyn Vital Signs Monitor 5300 Series 300 || Part numbers 007-0098-00 through 007-0159-00
  • Modelo / Serial
    Serial numbers JA000225 through JA002052.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Welch Allyn distributes product to hospitals, physicians and distributors nationwide and internationally.
  • Descripción del producto
    Welch Allyn Vital Signs Monitor 5300 Series 300 || Part numbers 007-0098-00 through 007-0159-00
  • Manufacturer
    Welch Allyn Protocol, Inc

Manufacturer

Welch Allyn Protocol, Inc
  • Dirección del fabricante
    Welch Allyn Protocol, Inc, 8500 SW Creekside Pl, Beaverton OR 97008-7107
  • Source
    USFDA