Events

Retiro De Equipo (Recall) de Device Recall Penlon Sigma Delta Vaporizer

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Penlon, Ltd..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    65286
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1653-2013
  • Fecha de inicio del evento
    2013-05-14
  • Fecha de publicación del evento
    2013-07-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-05-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118458
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Vaporizer, anesthesia, non-heated - Product Code CAD
  • Causa
    It has come to penlon ltd's attention of an instance where the installation and pre-use checks listed in the user manual may not have been followed prior to the clinical use of the vaporizer. penlon ltd has updated the installation and daily pre-use check sections of the user manual to ensure that the instructions are explicit and clear.
  • Acción
    Penlon sent an Urgent Field Safety Notice dated May 14, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were reminded and requested to follow the instructions for daily pre-use checks, initial checks, and servicing. Customers were instructed to distribute the notice to all personnel who need to be aware within their organization and to any organization where the devices are used. For questions regarding this recall call 01235 547000.

Device

Device Recall Penlon Sigma Delta Vaporizer
  • Modelo / Serial
    All; recalled products are traced by serial numbers D0312-XXXX to D1112-XXXX.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including FL, KY, PA, ND, MN, IL, NJ, TX, TN, and VA. Internationally to Belgium, China, Czech Republic, France, Germany, Switzerland, Australia, Finland, Holland, Lithunia, Malta, Poland, and Slovakia.
  • Descripción del producto
    Delta Vaporizer || An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.
  • Manufacturer
    Penlon, Ltd.

Manufacturer

Penlon, Ltd.
  • Dirección del fabricante
    Penlon, Ltd., Abingdon Science Park, Barton Lane, Abingdon United Kingdom
  • Empresa matriz del fabricante (2017)
    BPL Medical Technologies Pvt Ltd.
  • Source
    USFDA