Events

Retiro De Equipo (Recall) de Welch Allyn KleenSpec Corded Illumination 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 Welch Allyn 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
    72228
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0169-2016
  • Fecha de inicio del evento
    2015-10-02
  • Fecha de publicación del evento
    2015-10-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-05-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140278
  • 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
    Speculum, vaginal, nonmetal - Product Code HIB
  • Causa
    The firm became aware that the kleenspec¿ 788 corded illuminator has the potential to be incorrectly connected to a commonly available ac power cord instead of the illuminator low voltage transformer power cord which is supplied with the illuminator. this may result in a shattered lamp bulb and a potential electric shock hazard.
  • Acción
    On 10/02/2015, Welch Allyn commenced mailing of the Urgent Medical Device Correction letters (dated 10/01/2015) via UPS Certified Next Day Air Saver Mail. Welch Allyn then issued a 2nd notice dated 10/16/2015 to include an additional five (5) catalog numbers impacted by the issue. The letters inform customers of the issue and help customers avoid any such occurrences. Welch Allyn is provided supplementary User Precautions which re-emphasize safe use of this product and providing additional specificity to the warnings already on the labeling and packaging.

Device

Welch Allyn KleenSpec Corded Illumination System
  • Modelo / Serial
    all lots
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide, Puerto Rico and foreign distribution to the following countries: Australia, Bahamas, Bahrain, Belgium, Bermuda, Cambodia, Canada, Czech Republic, China, Cyprus, Denmark, Egypt, France, Germany, Great Britain, Greece, Guam, Guatemala, Iceland, India, Israel, Japan, Kenya, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sri Lanka, Thailand, Turkey, United Arab Emirates.
  • Descripción del producto
    Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting System, Model Number 78x Series Illuminator, REF 901070, Catalog Numbers 78800, 73410, 73412, 73414, 73416, 78810, 78812, 78814 and 78816, Rx ONLY
  • Manufacturer
    Welch Allyn Inc

Manufacturer

Welch Allyn Inc
  • Dirección del fabricante
    Welch Allyn Inc, 4341 State Street Rd, Skaneateles Falls NY 13153-5300
  • Empresa matriz del fabricante (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA