Events

Retiro De Equipo (Recall) de Device Recall Philips HeartStart FRx AED

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 Corp..

¿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
    79343
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1913-2018
  • Fecha de inicio del evento
    2018-03-14
  • 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=162082
  • 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
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Causa
    An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.
  • Acción
    Letters dated 2/16/2018 for U.S. customers were issued via certified mail on 3/14/2018. Letters to customers outside of the U.S. were localized in conjunction with the local Philips market organizations and are in progress.

Device

Device Recall Philips HeartStart FRx AED
  • Modelo / Serial
    Manufactured between September 2002 and February 2013. The year of manufacture can be identified by the 2nd and 3rd characters in the serial number on the back of the AED in the following ranges:  Home/Onsite: A02x-xxxxx through A13B-xxxxx; FRx: B04x-xxxxx through B13B-xxxxx  NOTE: If the device was manufactured in 2013 and the 4th digit is the letter "C" or later (D, E, F...), it is not covered by the recall (i.e. A13G-02375).  In some cases, a device within the date range covered by the notification did not contain a resistor previously associated with a failure. In that case, a notification was not sent. Confirmation as to whether the device contains the resistor at issue can be done by contacting the firm.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Distribution was nationwide and to Puerto Rico. There was also government/military distribution. Foreign distribution was made to the following countries: Canada, Afghanistan, Algeria, Argentina, Aruba, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Botswana, Brazil, Brunei Darussalam, Cambodia, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Fiji, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Malaysia, Malta, Mauritius, Mexico, Morocco, Namibia, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Niger, Norway, Oman, State of Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirate, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia, and Zimbabwe.
  • Descripción del producto
    Philips HeartStart FRx AED.
  • Manufacturer
    Philips Electronics North America Corp.

Manufacturer

Philips Electronics North America Corp.
  • Dirección del fabricante
    Philips Electronics North America Corp., 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA