Events

Alerte De Sécurité sur VENTAK PRIZM 2 DR, CONTAK RENEWAL and CONTAK RENEWAL 2, VENTAK PRIZM AVT, VITALITY AVT, RENEWAL 3 AVT and RENEWAL 4 AVT

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Guidant CorporationJune 18.

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
    2005-06-18
  • 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/press_guidant.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
    Press release
  • Cause
    Voluntary recall of implantable cardiac defibrillators by guidant corporationjune 18, 2005 the department of health today (june 18) noted a worldwide recall of certain implantable cardiac defibrillators issued by the guidant corporation today. the affected devices are – ventak prizm 2 dr (model 1861) icds manufactured on or before april 16, 2002 contak renewal (model h135) and contak renewal 2 (model h155) crt-ds manufactured on or before august 26, 2004 ventak prizm avt, vitality avt, renewal 3 avt and renewal 4 avt icds (all series numbers) individual patients implanted with affected devices should contact their attending doctors and keep regular appointment. in case they feel an electrical shock, or hear an audible “beeping” from the device, they should immediately contact their doctor or go to the nearest hospital emergency department. the department of health has informed public and private hospitals, medical professional associations and relevant patients’ groups about this recall action today. guidant corporation has posted information for physicians on its web site at www.Guidant.Com.

Device

VENTAK PRIZM 2 DR, CONTAK RENEWAL and CONTAK RENEWAL 2, VENTAK PRIZM AVT, VITALITY AVT, RENEWAL 3...
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Voluntary Recall of Implantable Cardiac Defibrillators by Guidant Corporation
  • Manufacturer
    Guidant CorporationJune 18

Manufacturer

Guidant CorporationJune 18
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH