Philips Heartstart FRx

  • Model / Serial
    DeviceSN: B10C-02133, B10C-02135, B10C-02136, B10C-02172, B10C-02196, B10C-02475, B10C-02477, B10C-02478, B10C-02480, B10C-02481, B10C-02494, B10C-02495, B10C-02499, B10C-02610, B10C-02631, B10C-02634, B10C-02639, B10C-02640, B10C-02641, B10C-02644, B10C-02645, B10C-02646, B10C-02647, B10C-02648, B10C-02651, B10C-02652, B10C-02653, B10C-02654, B10C-02655, B10C-02660, B10C-02674, B10C-02685, B10C-02702, B10C-02704, B10C-02705, B10C-02706, B10C-02707, B10C-02708, B10C-02709, B10C-02712, B10C-02713, B10C-02715, B10C-02717, B10C-02718, B10C-02719, B10C-02720, B10C-02721, B10C-02722, B10C-02723, B10C-02724, B10C-02725, B10C-02729, B10C-02732, B10C-02733, B10C-02734, B10C-02735, B10C-02736, B10C-02740, B10C-02742, B10C-02743, B10C-02744, B10C-02745, B10C-02746, B10C-02747, B10C-02749, B10C-02771, B10C-02779, B10C-02780, B10C-02781, B10C-02782, B10C-02783, B10C-02784, B10C-02785, B10C-02801, B10C-02805, B10C-02806, B10C-02816, B10C-02818, B10C-02822, B10C-02823, B10C-02824, B10C-02826, B10C-02830, B10C-02831, B10C-02832, B10C-02835, B10C-02836, B10C-02837, B10C-02838, B10C-02839, B10C-02840, B10C-02841, B10C-02843, B10C-02844, B10C-02845, B10C-02846, B10C-02847, B10C-02848, B10C-02849, B10C-02850, B10C-02851, B10C-02852, B10C-02853, B10C-02854, B10C-02855, B10C-02856, B10C-02858, B10C-02879, B10C-02881, B10C-02884, B10C-02886, B10C-02895, B10C-02896, B10C-02897, B10C-02900, B10C-02904, B10C-02905, B10C-02906, B10C-02907, B10C-02908, B10C-02909, B10C-02910, B10C-02911, B10C-02912, B10C-02913, B10C-02914, B10C-02915, B10C-02917, B10C-02919, B10C-02928, B10C-02929, B10C-02933, B10C-02937, B10C-02938, B10C-02943, B10C-02947, B10C-02948, B10C-02949, B10C-02950, B10C-02957, B10C-02965, B10C-03018, B10C-03019, B10C-03020, B10C-03021, B10C-03023, B10C-03024, B10C-03026, B10C-03040, B10C-03041, B10C-03042, B10C-03043, B10C-03045, B10C-03046, B10C-03047, B10C-03048, B10C-03049, B10C-03050, B10C-03119, B10C-03120, B10C-03121, B10C-03122, B10C-03123, B10C-03124, B10C-03125, B10C-03126, B10C-03127, B10C-03128, B10C-03156, B10C-03157, B10C-03158, B10C-03159, B10C-03160, B10C-03171, B10C-03175, B10C-03176, B10C-03178, B10C-03179, B10C-03180, B10C-03182, B10C-03194, B10C-03195, B10C-03196, B10C-03197, B10C-03198, B10C-03199, B10C-03200, B10C-03202, B10C-03203, B10C-03204, B10C-03205, B10C-03207, B10C-03208, B10C-03212, B10C-03213, B10C-03218, B10C-03247, B10C-03248, B10C-03251, B10C-03253, B10C-03255, B10C-03256, B10C-03257, B10C-03258, B10C-03259, B10C-03260, B10C-03262, B10C-03263, B10C-03265, B10C-03266, B10C-03267, B10C-03268, B10C-03269, B10C-03270, B10C-03271, B10C-03272, B10C-03273, B10C-03274, B10C-03275, B10C-03276, B10C-03286, B10C-03287, B10C-03288, B10C-03289, B10C-03290, B10C-03291, B10C-03292, B10C-03293, B10C-03295, B10C-03296, B10C-03297, B10C-03310, B10C-03329, B10C-03330, B10C-03332, B10C-03334, B10C-03335, B10C-03336, B10C-03338, B10C-03339, B10C-03340, B10C-03342, B10C-03349, B10C-03350, B10C-03355, B10C-03359, B10C-03360, B10C-03361, B10C-03362, B10C-03363, B10C-03364, B10C-03366, B10C-03367, B10C-03369, B10C-03384, B10C-03386, B10C-03437, B10C-03450, B10C-03451, B10C-03452, B10C-03453, B10C-03483, B10C-03484, B10C-03486, and B10C-03901.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Canada, Japan, United Arab Emirates, Austria, Switzerland, Germany, Spain, France, Italy, and Norway.
  • Product Description
    Automated External Defibrillator (AED) of brand name "Philips HeartStart FRx" (Model number 861304). || Device is designed for use on a person in sudden cardiac arrest who is unresponsive when shaken and not breathing normally
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Philips Medical Systems, 2301 5th Ave Ste 200, Seattle WA 98121
  • Source
    USFDA

7 devices with a similar name

Learn more about the data here

  • Model / 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.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    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.
  • Product Description
    Philips HeartStart FRx AED.
  • Manufacturer
  • Model / Serial
    Serial Number: B08G-01884
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution: to one account in Arkansas.
  • Product Description
    Philips HeartStart FRx Defibrillator, Automated External Defibrillator (AED), catalog number 861304.
  • Manufacturer
  • Model / Serial
    1)Philips brand FRx Model Number 861304 under 510(k) K050004, sold nationally and Internationally, Serial numbers range from BO4L-00001 through B12F-00286 and represents 181,226 devices; 2) Laerdal brand FRx Model Number 861305 unfrt 510(k) K050004, sold nationally and Internationally, serial numbers range from B04L-00013 through B12E-04135 and represents 20,372 devices.  Please note the serial number range represents first and last serial number for each model. Serial numbers are not continguous.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Japan and Malaysia.
  • Product Description
    Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 || The FRx 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 FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.
  • Manufacturer
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