Events

Alerte De Sécurité sur Pedi-Padz Reduced Energy Electrode, Model # 8900-0401

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Zoll Medical Corporation.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2012-02-09
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120209.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Field safety notice: zoll pedi-padz reduced energy electrode, model # 8900-0401 health canada, has issued a type ii recall on pedi-padz reduced energy electrode, model # 8900-0401, manufactured by zoll medical corporation. according to the manufacturer, the products are being recalled because a problem was identified through the supplier’s internal quality system on a production lot. the issue is the lack of an adequate silicone seal around the periphery of the attenuator enclosure which houses an in-line series of resistors designed to restrict the level of energy being transmitted to a pediatric recipient during defibrillation. the affected lot numbers were from 0511 to 4511. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to the health canada website: http://hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/ _list/rec-ret_md-im_date_jan-mar_2012-eng.Php if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Pedi-Padz Reduced Energy Electrode, Model # 8900-0401
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Zoll Pedi-Padz Reduced Energy Electrode, Model # 8900-0401
  • Manufacturer
    Zoll Medical Corporation

Manufacturer

Zoll Medical Corporation