Events

Recall of Philips Heartstart FRx

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    55579
  • Event Risk Class
    Class 2
  • Event Number
    Z-1915-2010
  • Event Initiated Date
    2010-04-30
  • Event Date Posted
    2010-06-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91190
  • Notes / Alerts
    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.
  • Extra notes in the data
    Automated External Defibrillator - Product Code MKJ
  • Reason
    Seventeen aeds failed production line testing (final acceptance test).
  • Action
    The firm notified U.S. distributors on 4/30/2010 via phone call and e-mail to obtain consignee location information. A website providing information was activated on 4/30/2010. On 5/3/2010 Urgent Medical Device Recall letters, dated April 29, 2010 were sent to direct customers in the US. The letters explained the reason for the recall and Customers were asked to verify that they have the product subject to recall. Replacement AEDs will be provided at no charge to the customer. Field Safety Notices were attached to the letters and provided a list of actions for customers to take. Customers should check the serial number on their devices against the list provided, contact Philips Healthcare to arrange for replacement, and ensure that necessary staff are aware of the recall. For further information and support, Philips Healthcare should be contacted at 1-800-263-3342.

Device

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
    Cardiovascular Devices
  • 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
    Philips Medical Systems

Manufacturer

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