Retiro De Equipo (Recall) de Device Recall automated external defibrillator

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.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    A potential exists for a component failure, which, if it occurs, could result in the inability to deliver therapy.
  • Acción
    On September 28, 2009 Philips issued a nationwide press release. On October 1, 2009 the firm issued notification letters to consignees arranging for the return and replacement of the affected units. The firm also set up a page on their website with a serial number look-up tool. For further information or support concerning this issue, customers are asked to contact Philips at 1.800.263.3342 or visit for the serial number look-up list, answers to frequently asked questions, directions for the battery insertion test, and the replacement AED selection form.


  • Modelo / Serial
    The following letter codes are used in conjunction with the catalog numbers to indicate language of Instructions for Use (IFU) and FR2+ voice prompts: ABA=U.S. English; ABU=U.K. English; ABD=German; ABE=Spanish; ABF=French; ABH=Dutch; ABI=Hong Kong; ABJ=Japanese; ABN=Norwegian; ABO=Taiwanese; ABS=Swedish; ABX=Finland; ABZ=Italian; AB2=China; and  AC4=Portugal.  Additional (non-language related) letter codes for product: A01=Product with TSO (Technical Standard Order) approved battery; and RF=Service Replacement.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Domestic and Worldwide distribution to: United States, Canada, Australia, Austria, Bulgaria, China, Finland, France, Germany, Gibraltar, Great Britain, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Jordan, Lebanon, Malaysia, Mexico, Netherlands, Norway, Portugal, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Arab Emirates.
  • Descripción del producto
    Heartstart FR2+ automated external defibrillator models M3861A and M3841A are NOT equipped with the ECG Module. || Model M3861A is under the Philips label and M3841A is under the Laerdal label.
  • Manufacturer


  • Dirección del fabricante
    Philips Medical Systems, 2301 5th Ave Ste 200, Seattle WA 98121
  • Source