Events

Alerta De Seguridad para VENTAK PRIZM 2 DR, CONTAK RENEWAL and CONTAK RENEWAL 2, VENTAK PRIZM AVT, VITALITY AVT, RENEWAL 3 AVT and RENEWAL 4 AVT

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Guidant CorporationJune 18.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2005-06-18
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/press_guidant.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Press release
  • Causa
    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...
  • Modelo / Serial
  • Descripción del producto
    Press release: Voluntary Recall of Implantable Cardiac Defibrillators by Guidant Corporation
  • Manufacturer
    Guidant CorporationJune 18

Manufacturer

Guidant CorporationJune 18
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “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