Recall of Device Recall Heartstart

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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 Defibrillators (Non-Wearable) - Product Code MKJ
  • Reason
    Potential for failure of a capacitor during use which would prevent the aed from delivering effective defibrillation therapy when indicated.
  • Action
    The firm notified their US distributors of the recall and instructed them to contact customers and provide information how to return the product to Philips for a free replacement. Firm contacted distributors via phone and email on 11/2/09 and by letter on 11/9/09. A web site providing information related to the recall was activated on 11/3/09.


  • Model / Serial
    DOMESTIC UNIT SERIAL NUMBERS - A09J-01665, A09J-01237, A09J-02203, A09J-01279, A09J-01353, A09J-01284, A09J-01227, A09J-01593, A09J-01236, A09J-01238, A09J-01667, A09J-02140, A09J-02230, A09J-02238, A09J-01351, A09J-02218, A09J-01183, A09J-01232, A09J-01275, A09J-01277, A09J-01280, A09J-01283, A09J-01285, A09J-01286, A09J-01289, A09J-01290, A09J-01291, A09J-01654, A09J-01663, A09J-01669, A09J-01670, A09J-01727, A09J-02002, A09J-02139, A09J-02147, A09J-02148, A09J-02149, A09J-02202, A09J-02208, A09J-02211, A09J-02213, A09J-02219, A09J-02222, A09J-02224, A09J-02225, A09J-02226, A09J-02227, A09J-02228, A09J-02229, A09J-01354, A09J-01656, A09J-01664, A09J-02201, A09J-01229, A09J-01230, A09J-01287, A09J-01651, A09J-01652, A09J-01653, A09J-01657, A09J-01659, A09J-01660, A09J-01662, A09J-01666, A09J-01668, A09J-01225, A09J-01226, A09J-01231, A09J-01235, A09J-01329, A09J-01339, A09J-01356, A09J-01358, A09J-01655, A09J-01658, A09J-01661, A09J-01674, A09J-01675, A09J-01701, A09J-01708, A09J-01710, A09J-02102, A09J-02138, A09J-01153, A09J-01424, A09J-01426, A09J-01732, A09J-01733, A09J-01734, A09J-01736, A09J-02214, A09J-02221, A09J-02239, A09J-01292, A09J-01296, A09J-01297, A09J-01331, A09J-02235, and A09J-02237.   INTERNATIONAL UNIT SERIAL NUMBERS - A09J-02145, A09J-02204, A09J-01298, A09J-02207, A09J-02209, A09J-02223, A09J-02236, A09J-02142, A09J-02210, A09J-01829, A09J-01839, A09J-01847, A09J-01849, A09J-01860, A09J-01873, A09J-01874, A09J-01876, A09J-01897, A09J-01941, A09J-01942, A09J-01943, A09J-01948, A09J-02012, A09J-02272, A09J-02304, A09J-02348, A09J-02501, A09J-02502, A09J-02505, A09J-02510, A09J-02512, A09J-02614, A09J-02629, A09J-02630, A09J-02634, A09J-02668, A09J-02681, A09J-01878, A09J-01880, A09J-01881, A09J-02515, A09J-02545, A09J-02609, A09J-02686, A09J-01879, A09J-01918, A09J-02618, A09J-01894, A09J-02028, A09J-02282, A09J-02504, A09J-02513, A09J-02698, A09J-01883, A09J-02022, A09J-02047, A09J-02174, A09J-02178, A09J-02184, A09J-02186, 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A09J-01252, A09J-01253, A09J-01254, A09J-01255, A09J-01257, A09J-01258, A09J-01259, A09J-01260, A09J-01261, A09J-01262, A09J-01263, A09J-01264, A09J-01265, A09J-01266, A09J-01267, A09J-01272, A09J-01273, A09J-01288, A09J-01293, A09J-01294, A09J-01295, A09J-01299, A09J-01300, A09J-01301, A09J-01302, A09J-01303, A09J-01311, A09J-01313, A09J-01316, A09J-01318, A09J-01319, A09J-01320, A09J-01321, A09J-01322, A09J-01323, A09J-01324, A09J-01325, A09J-01326, A09J-01327, A09J-01328, A09J-01332, A09J-01333, A09J-01334, A09J-01335, A09J-01336, A09J-01337, A09J-01338, A09J-01341, A09J-01342, A09J-01343, A09J-01344, A09J-01345, A09J-01346, A09J-01347, A09J-01348, A09J-01350, A09J-01352, A09J-01357, A09J-01359, A09J-01360, A09J-01361, A09J-01363, A09J-01364, A09J-01365, A09J-01366, A09J-01367, A09J-01368, A09J-01369, A09J-01370, A09J-01371, A09J-01372, A09J-01373, A09J-01374, A09J-01375, A09J-01376, A09J-01377, A09J-01378, A09J-01379, A09J-01380, A09J-01381, A09J-01382, A09J-01383, A09J-01384, 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A09J-02435, A09J-02436, A09J-02437, A09J-02438, A09J-02439, A09J-02440, A09J-02441, A09J-02443, A09J-02444, A09J-02448, A09J-02449, A09J-02508, A09J-02509, A09J-02511, A09J-02557, A09J-02573, A09J-02574, A09J-02575, A09J-02578, A09J-02582, A09J-02583, A09J-02585, A09J-02586, A09J-02588, A09J-02589, A09J-02590, A09J-02591, A09J-02592, A09J-02593, A09J-02594, A09J-02595, A09J-02596, A09J-02597, A09J-02599, A09J-02621, A09J-02623, A09J-02648, A09J-02651, A09J-02652, A09J-02653, A09J-02654, A09J-02655, A09J-02656, A09J-02657, A09J-02658, A09J-02659, A09J-02660, A09J-02662, A09J-02663, A09J-02664, A09J-02665, A09J-02666, A09J-02667, A09J-02669, A09J-02670, A09J-02673, A09J-02674, A09J-02676, A09J-02677, A09J-02678, A09J-02679, A09J-02680, A09J-02682, A09J-02684, A09J-02685, A09J-02687, A09J-02688, A09J-02689, A09J-02690, A09J-02692, A09J-02694, A09J-02695, A09J-02696, A09J-02697, A09J-02699, A09J-02701, A09J-02702, A09J-02703, A09J-02704, A09J-02705, A09J-02707, A09J-02708, A09J-02715, A09J-02716, A09J-02717, A09J-02718, A09J-02719, A09J-02720, A09J-02721, A09J-02723, A09J-02725, A09J-02726, A09J-02728, A09J-02729, A09J-02730, A09J-02731, A09J-02732, A09J-02733, A09J-02734, A09J-02736, A09J-02740, A09J-02741, A09J-02742, A09J-02743, A09J-02744, A09J-02745, A09J-02746, A09J-02747, A09J-02762, A09J-02765, A09J-02776, A09J-02777, A09J-02778, A09J-02779, A09J-02781, A09J-02783, A09J-02786, A09J-02794, A09J-02796, A09J-02801, A09J-02802, A09J-02803, A09J-02804, A09J-02805, A09J-02806, A09J-02816, A09J-02839, A09J-02840, A09J-02843, A09J-02844, A09J-02845, A09J-02846, A09J-02847, A09J-02852, A09J-02854, A09J-02858, A09J-02859, A09J-02860, A09J-02861, A09J-02862, A09J-02865, A09J-02866, A09J-02877, A09J-02903, A09J-02909, A09J-02913, A09J-02915, A09J-02916, A09J-02917, A09J-02918, A09J-02919, A09J-02920, A09J-02921, A09J-02922, A09J-02923, A09J-02924, A09J-02925, A09J-02926, A09J-02927, A09J-02928, A09J-02929, A09J-02933, A09J-02936, A09J-02938, A09J-02939, A09J-02940, A09J-02941, A09J-02942, A09J-02943, A09J-02944, A09J-02945, A09J-02946, A09J-02947, A09J-02948, A09J-02949, A09J-02953, A09J-02954, A09J-02955, A09J-02958, A09J-03009, A09J-03010, A09J-03011, A09J-03012, A09J-03013, A09J-03014, A09J-03015, A09J-03016, A09J-03017, A09J-03020, A09J-03021, A09J-03022, A09J-03023, A09J-03025, A09J-03027, A09J-03030, A09J-03035, A09J-03042, A09J-03048, A09J-03055, A09J-03056, A09J-03070, A09J-00940, A09J-01115, A09J-01174, A09J-01175, A09J-01256, A09J-01421, A09J-01434, A09J-01613, A09J-01614, A09J-01615, A09J-01616, A09J-01617, A09J-01621, A09J-01622, A09J-01623, A09J-01625, A09J-01626, A09J-01627, A09J-01643, A09J-01644, A09J-01645, A09J-01647, A09J-01650, A09J-01711, A09J-01712, A09J-01713, A09J-01715, A09J-01718, A09J-01719, A09J-01726, A09J-01731, A09J-01758, A09J-01761, A09J-01762, A09J-01770, A09J-01772, A09J-01773, A09J-01791, A09J-01792, A09J-01799, A09J-01852, A09J-01853, A09J-01854, A09J-01855, A09J-01857, A09J-01858, A09J-01861, A09J-01863, A09J-01864, A09J-01866, A09J-01968, A09J-01971, A09J-01972, A09J-01978, A09J-01979, A09J-01981, A09J-01997, A09J-01998, A09J-01999, A09J-02000, A09J-02007, A09J-02014, A09J-02015, A09J-02016, A09J-02024, A09J-02031, A09J-02032, A09J-02048, A09J-02053, A09J-02054, A09J-02090, A09J-02092, A09J-02095, A09J-02101, A09J-02103, A09J-02105, A09J-02106, A09J-02107, A09J-02109, A09J-02112, A09J-02115, A09J-02120, A09J-02121, A09J-02126, A09J-02128, A09J-02131, A09J-02132, A09J-02134, A09J-02135, A09J-02136, A09J-02141, A09J-02143, A09J-02144, A09J-02215, A09J-02216, A09J-02220, A09J-02231, A09J-02232, A09J-02233, A09J-02234, A09J-02277, A09J-02302, A09J-02306, A09J-02307, A09J-02315, A09J-02316, A09J-02318, A09J-02357, A09J-02368, A09J-02369, A09J-02700, A09J-01304, A09J-01340, A09J-01896, A09J-01928, A09J-02168, A09J-02518, A09J-02527, A09J-02541, A09J-01926, A09J-01803, A09J-01832, A09J-01833, A09J-01841, A09J-01929, A09J-01932, A09J-02037, A09J-02157, A09J-02281, A09J-02300, A09J-02519, A09J-02522, A09J-02523, A09J-02525, A09J-02528, A09J-02612, A09J-02349, A09J-01869, A09J-01875, A09J-02029, A09J-02050, A09J-02649, A09J-01898, A09J-02507, A09J-02524, A09J-02526, A09J-01820, A09J-01834, A09J-01843, A09J-01927, A09J-02154, A09J-02155, A09J-02158, A09J-02160, A09J-02166, A09J-02516, A09J-02517, A09J-02520, A09J-02529, A09J-02548, A09J-02620, A09J-02671, A09J-02672, A09J-02683, A09J-01842, A09J-01899, A09J-01967, A09J-02167, A09J-02283, and A09J-02530.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution.
  • Product Description
    Philips Heartstart (HS1) Onsite Automated External Defibrillator (AED) Catalog number M5066A
  • Manufacturer


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