Events

Retiro De Equipo (Recall) de Device Recall Philips and Laerdal brands of HeartStart HS1 Defibrillator Family

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 Medical Systems North America Co. Phillips.

¿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
    63030
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0643-2013
  • Fecha de inicio del evento
    2012-07-26
  • Fecha de publicación del evento
    2013-01-04
  • 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=113133
  • 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
    Philips determined that it is important to clarify information in the owner's manual and keep customers informed about the maintenance of their frx (models 861304 and 861305), onsite (models m5066a and m5067a), or heartstart home (model m5068a) automated external defibrillators (aeds) shipped between december 2005 and july 2012. philips had determined there is a need to emphasize the importance o.
  • Acción
    Philips Healthcare sent an Emergency Care and Resuscitation letter Customer Information Letter dated July 26, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their Philip's representative to obtain the tools and information they need to ensure that their device is functioning properly. For questions regarding this recall, please call AED Recall Support at 1-800-263-3342 (Option 6).

Device

Device Recall Philips and Laerdal brands of HeartStart HS1 Defibrillator Family
  • Modelo / Serial
    HS1 product family all start with A in the serial number and break down into 3 catalog numbers - M5066A, M5067A and M5068A:  1) M5066A (referred to as Onsite or HS1), Philips brand, 510 (k) = K020715, sold nationally and internationally, serial numbers range from A021-00038 through A12E-03490, with 306,108 total devices.  2) M5067A, Philips brand 510(k) = K040904, sold nationally and internationally, serial numbers range from A05C-00727 through A12D-01406, with 978 total devices.  3) M5068A, Philips brand 510(k) = K020715, sold nationally and internationally, serial numbers range from A021J-00207 through A12E-01900, with 22,760 total devices   4) M5066A, Laerdal brand, 510 (k) = K020715, sold internationally, serial numbers range from A021-00036 through A12D-02148, with 60,433 total devices.  5) M5067A, Laerdal brand, sold as Home device- cleared for OTC on initial 510(k) = K040904, serial numbers range from A021-00133 through A11B-00970, with 8659 total devices.  6) M5068A, Laerdal brand, 510(k) = K020715, sold internationally, serial numbers range from A02K-00172 through A11H-00868, with 5217 total devices.  Please note the serial number range represents first and last serial number for each model. Serial numbers are not continguous.  Laerdal is a distribution partner in EU and Canada, sold internationally
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Japan and Malaysia.
  • Descripción del producto
    Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. || The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • Dirección del fabricante
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA