Events

Retiro De Equipo (Recall) de Device Recall Philips

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 Philips Electronics North America Corporation.

¿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
    74616
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2670-2016
  • Fecha de inicio del evento
    2016-07-07
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148175
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Causa
    Increase in the failure rate of certain low-voltage dc power supplies (dcps).
  • Acción
    Philips sent an Urgent - Field Safety Notice dated June 20, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Philips Field Service Engineers will replace the affected DCPS free of charge. If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377. For further questions regarding this recall please call (978) 659-3000.

Device

Device Recall Philips
  • Modelo / Serial
    UNIQ with release R1.0
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide, Canada, Algeria Argentina Australia Austria Bahrain Bangladesh Belgium Brazil Brunei Darussalam Bulgaria CHILE China Colombia Croatia Cuba Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt Finland France French Polynesia Georgia Germany Greece Honduras Hong Kong Hungary Iceland India Indonesia Iran Ireland Israel Italy Japan Jordan Kazakhstan Kenya Korea, Republic of Lebanon Lithuania Macedonia Malaysia Malta Mexico Morocco Myanmar Nepal Netherlands New Caledonia Norway Oman Pakistan Palestine, State of PERU Philippines Poland Portugal Qatar R¿union Romania RUSSIAN FEDERAT Russian Federation Saudi Arabia Singapore Slovakia South Africa Spain Sri Lanka Sweden Switzerland Taiwan Tanzania Thailand Tunisia Turkey Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Viet Nam
  • Descripción del producto
    UNIQ 1.0: UNIQ FD10, 722026; UNIQ FD10/10, 722027; UNIQ FD20, 722028; UNIQ FD20/10 biplane, 722029; UNIQ FD10 OR Table, 722033; UNIQ FD10/10 OR Table, 722034; UNIQ FD20 OR Table, 722035; UNIQ FD20/20, 722038; || UNIQ FD20/20 biplane OR Table, 722039; UNIQ FD20/15, 722058; UNIQ FD20/15 OR Table 722059
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • Dirección del fabricante
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA