Events

Retiro De Equipo (Recall) de Device Recall Philips HeartStart XL Defibrillator/Monitor

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 Healthcare Inc..

¿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
    64201
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0871-2013
  • Fecha de inicio del evento
    2013-01-28
  • Fecha de publicación del evento
    2013-02-21
  • 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=115542
  • 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 heartstart xl+ defibrillator/monitor may become locked out of clinical use.
  • Acción
    Philips Healthcare sent an Urgent Medical Device Recall letter dated January 2013 on January 28, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised if the Philips HeartStart XL+ Defibrillator/Monitor is first powered on and then there is disconnection or an interruption in AC power, the device may be locked out of clinical mode until the user enters the service mode password and performs an Operational Check. Users are provided with the Safety Notice that provides information on how to identify affected devices and instructions on actions to be taken. Customers were advised to follow the ACTION TO BE TAKEN BY CUSTOMER / USER section of the notice. To correct this issue Philips will provide a software upgrade to customers with affected units free of charge. If you need any further information or support concerning this issue, please contact your local Philips representative at 1-800-722-9377. For questions regarding this recall call 978-687-1501.

Device

Device Recall Philips HeartStart XL Defibrillator/Monitor
  • Modelo / Serial
    Serial number range: USO1100100 - USO1100372,  USN1100376 - USN1100960, USD1100961 - USD1101095,  US11201096 - US11201186,  US21201187 - US21201239,  US31201240 - US31201537,  US41201538 - US41201585,  US51201586 - US51201721,  US61201722 -US61201924,  US71201925 - US71202048,  US81202049 - US81202168, US91202169- US91202514,  USO1202515 - USO1202990,  USN1202991 - USN1203537,  USD1203538- USD1203968,  US11303969 - US11303972
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to ALGERIA, ANGOLA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BULGARIA, COLOMBIA, CROATIA (LOCAL NAME HYVATSKA), CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGYPT, ESTONIA, FINLAND, FRANCE, GABON, GERMANY, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN (ISLAMIC REPUBLIC OF), IRAQ, IRELAND, ISRAEL, ITALY, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MALAYSIA, MALTA, MAURITIUS, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PALESTINE, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA (SLOVAK REPUBLIC), SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TANZANIA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, AND VIET NAM.
  • Descripción del producto
    Philips HeartStart XL+ Defibrillator/Monitor || Model number: 861290 || The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • Dirección del fabricante
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA