Events

Alerta De Seguridad para ICD TELIGEN, Model Nos.: F102, F103, F110, F111 and CRT-D COGNIS, Model Nos.: P107 and P108

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

¿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
    2012-03-14
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120314a.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
    Medical Device Safety Alert
  • Causa
    Field safety notice: boston scientific icd teligen, model nos.: f102, f103, f110, f111 and crt-d cognis, model nos.: p107 and p108 it comes to our attention that the state institute for drug control, czech republic received information from boston scientific that the below implantable cardioverter-defibrillator (icd) and defibrillator for cardiac resynchronization therapy (crt-d) were stolen from the service car of clinical engineer on march 01, 2012 in the territory of the czech republic. trade name model no. material no. serial no. expiration date icd teligen_he vr df1 f102 60f102-814 113139 4.8.2012 icd teligen_he vr df1 f102 60f102-814 114621 9.12.2012 icd teligen_he vr df4 f103 60f103-805 116879 16.12.2012 icd teligen_he dr df1 f110 60f110-814 117249 10.8.2012 icd teligen_he dr df4 f111 60f111-805 104766 6.7.2012 icd teligen_he dr df4 f111 60f111-805 104769 6.7.2012 crt-d cognis_he df1/is1 p107 60p107-814 113354 14.5.2012 crt-d cognis_he df1/is1 p107 60p107-814 115530 29.7.2012 crt-d cognis_he df4 p108 60p108-805 107564 4.10.2012 crt-d cognis_he df4 p108 60p108-805 107572 4.10.2012 crt-d cognis_he df4 p108 60p108-805 107921 10.11.2012 if you are in possession of the affected product, please contact boston scientific for necessary actions.

Device

ICD TELIGEN, Model Nos.: F102, F103, F110, F111 and CRT-D COGNIS, Model Nos.: P107 and P108
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Boston Scientific ICD TELIGEN, Model Nos.
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • 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