Events

Rappel de Welch Allyn KleenSpec Corded Illumination System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Welch Allyn Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    72228
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0169-2016
  • Date de mise en oeuvre de l'événement
    2015-10-02
  • Date de publication de l'événement
    2015-10-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-05-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140278
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Speculum, vaginal, nonmetal - Product Code HIB
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    all lots
  • Classification du dispositif
    Obstetrical and Gynecological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Welch Allyn Inc, 4341 State Street Rd, Skaneateles Falls NY 13153-5300
  • Société-mère du fabricant (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA