HeartStart FRx

Fabricant

  • Société-mère du fabricant (2017)
  • Source
    SATP

31 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    Philips HeartStart FRx AED.
  • Manufacturer
  • Modèle / numéro de série
    Philips AED Models: HeartStart FRx, HeartStart Home, and HeartStart OnSite AEDs manufactured from September 2002 through February 2013 are included within the scope of this notification because they may contain the type of resistor that has previously been associated with a failure. 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 range: Home/Onsite:(02)I-xxxxx through A 13(B-)xxxxx FRxB(04)L-xxxxx through B13(B-)xxxxx
  • Description du dispositif
    Defibrillator/Cardioverters
  • Manufacturer
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