Events

Rappel de Device Recall Heartstart

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Philips Medical Systems.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    53816
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1193-2010
  • Date de mise en oeuvre de l'événement
    2009-11-02
  • Date de publication de l'événement
    2010-03-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-05-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86576
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Automated External Defibrillators (Non-Wearable) - Product Code MKJ
  • Cause
    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.

Device

Device Recall Heartstart
  • Modèle / numéro de série
    DOMESTIC UNIT SERIAL NUMBERS - B09J-00860, B09J-00792, B09J-00810, B09J-00877, B09J-00878, B09J-00793, B09J-01110, B09J-00849, B09J-01016, B09J-01196, B09J-01299, B09J-00855, B09J-00805, B09J-01193, B09J-00896, B09J-00824, B09J-00821, B09J-00823, B09J-00825, B09J-00835, B09J-02749, B09J-00794, B09J-00856, B09J-00889, B09J-00891, B09J-00897, B09J-01005, B09J-01012, B09J-01197, B09J-01230, B09J-01269, B09J-01279, B09J-00791, B09J-00818, B09J-00875, B09J-01082, B09J-01100, B09J-01260, B09J-01010, B09J-01018, B09J-01021, B09J-01022, B09J-01108, B09J-01114, B09J-01120, B09J-01080, B09J-01014, B09J-01298, B09J-01300, B09J-01257, B09J-00872, B09J-00803, B09J-00804, B09J-00868, B09J-01013, B09J-01019, B09J-01020, B09J-01123, B09J-01258, B09J-00786, B09J-00817, B09J-00790, B09J-00816, B09J-01122, B09J-01162, B09J-00789, B09J-00795, B09J-00798, B09J-00806, B09J-00807, B09J-00808, B09J-00842, B09J-00847, B09J-00879, B09J-00892, B09J-01002, B09J-01003, B09J-01006, B09J-01007, B09J-00813, B09J-00819, B09J-00820, B09J-00853, B09J-00884, B09J-01015, B09J-01139, B09J-01252, B09J-01259, B09J-00787, B09J-01253, B09J-01303, and B09J-00898. I   INTERNATIONAL UNIT SERIAL NUMBERS - B09J-02902, B09J-02630, B09J-02914, B09J-02920, B09J-02921, B09J-01243, B09J-02588, B09J-02802, B09J-02911, B09J-02929, B09J-02918, B09J-02398, B09J-02744, B09J-02922, B09J-02935, B09J-01078, B09J-01341, B09J-01348, B09J-01349, B09J-01350, B09J-01364, B09J-01365, B09J-01369, B09J-01373, B09J-01375, B09J-01388, B09J-01390, B09J-01391, B09J-01392, B09J-01393, B09J-01395, B09J-01396, B09J-01397, B09J-01398, B09J-01399, B09J-01401, B09J-01402, B09J-01403, B09J-01407, B09J-01409, B09J-01411, B09J-01414, B09J-01424, B09J-01425, B09J-01428, B09J-01440, B09J-01443, B09J-01460, B09J-01461, B09J-01462, B09J-01463, B09J-01501, B09J-01515, B09J-01516, B09J-01520, B09J-01523, B09J-01524, B09J-01530, B09J-01531, B09J-01532, B09J-01533, B09J-01534, B09J-01535, B09J-01544, B09J-01545, B09J-01546, B09J-01547, B09J-01548, B09J-01549, B09J-01601, B09J-01602, B09J-01603, B09J-01604, B09J-01605, B09J-01606, B09J-01607, B09J-01630, B09J-01636, B09J-01637, B09J-01639, B09J-01640, B09J-01641, B09J-01642, B09J-01646, B09J-01647, B09J-01648, B09J-01651, B09J-01659, B09J-01660, B09J-01662, B09J-01664, B09J-01667, B09J-01668, B09J-01677, B09J-01678, B09J-01680, B09J-01681, B09J-01682, B09J-01683, B09J-01685, B09J-01687, B09J-01688, B09J-01689, B09J-01690, B09J-01691, B09J-01695, B09J-01696, B09J-01699, B09J-01700, B09J-01701, B09J-01702, B09J-01703, B09J-01704, B09J-01705, B09J-01706, B09J-01709, B09J-01712, B09J-01715, B09J-01716, B09J-01717, B09J-01718, B09J-01719, B09J-01720, B09J-01721, B09J-01722, B09J-01723, B09J-01724, B09J-01725, B09J-01726, B09J-01727, B09J-01728, B09J-01729, B09J-01730, B09J-01731, B09J-01733, B09J-01734, B09J-01735, B09J-01737, B09J-01738, B09J-01739, B09J-01740, B09J-01741, B09J-01742, B09J-01743, B09J-01744, B09J-01745, B09J-01746, B09J-01747, B09J-01748, B09J-01749, B09J-01750, B09J-01751, B09J-01752, B09J-01753, B09J-01754, B09J-01755, B09J-01756, B09J-01757, B09J-01758, B09J-01759, B09J-01760, B09J-01761, B09J-01762, B09J-01765, B09J-01766, B09J-01768, B09J-01769, B09J-01770, B09J-01771, B09J-01772, B09J-01773, B09J-01775, B09J-01776, B09J-01777, B09J-01778, B09J-01779, B09J-01780, B09J-01781, B09J-01782, B09J-01784, B09J-01785, B09J-01786, B09J-01787, B09J-01788, B09J-01789, B09J-01792, B09J-01793, B09J-01794, B09J-01795, B09J-01796, B09J-01797, B09J-01798, B09J-01800, B09J-01802, B09J-01803, B09J-01804, B09J-01807, B09J-01809, B09J-01828, B09J-01831, B09J-01832, B09J-01834, B09J-01836, B09J-01837, B09J-01838, B09J-01841, B09J-01842, B09J-01843, B09J-01844, B09J-01845, B09J-01856, B09J-01870, B09J-01871, B09J-01872, B09J-01873, B09J-01874, B09J-01875, B09J-01876, B09J-01877, B09J-01878, B09J-01879, B09J-01880, B09J-01882, B09J-01883, B09J-01884, B09J-01885, B09J-01888, B09J-01891, B09J-01893, B09J-01894, B09J-01897, B09J-01898, B09J-01899, B09J-01901, B09J-01902, B09J-01903, B09J-01904, B09J-01905, B09J-01906, B09J-01907, B09J-01908, B09J-01909, B09J-01910, B09J-01911, B09J-01912, B09J-01913, B09J-01914, B09J-01915, B09J-01917, B09J-01918, B09J-01920, B09J-01928, B09J-01930, B09J-01932, B09J-01942, B09J-01944, B09J-01946, B09J-01948, B09J-01949, B09J-01950, B09J-01951, B09J-01953, B09J-01954, B09J-01955, B09J-01956, B09J-01957, B09J-01958, B09J-01959, B09J-01962, B09J-01963, B09J-01964, B09J-01970, B09J-01971, B09J-01972, B09J-01976, B09J-01980, B09J-01982, B09J-01987, B09J-01988, B09J-01992, B09J-01994, B09J-01995, B09J-01997, B09J-02001, B09J-02003, B09J-02004, B09J-02005, B09J-02006, B09J-02007, B09J-02008, B09J-02009, B09J-02011, B09J-02012, B09J-02018, B09J-02020, B09J-02021, B09J-02023, B09J-02029, B09J-02031, B09J-02046, B09J-02047, B09J-02050, B09J-02051, B09J-02057, B09J-02060, B09J-02061, B09J-02063, B09J-02064, B09J-02065, B09J-02066, B09J-02067, B09J-02069, B09J-02092, B09J-02101, B09J-02103, B09J-02106, B09J-02109, B09J-02121, B09J-02122, B09J-02132, B09J-02133, B09J-02134, B09J-02135, B09J-02137, B09J-02143, B09J-02146, B09J-02148, B09J-02149, B09J-02154, B09J-02156, B09J-02161, B09J-02162, B09J-02168, B09J-02171, B09J-02179, B09J-02261, B09J-02263, B09J-02265, B09J-02269, B09J-02272, B09J-02273, B09J-02276, B09J-02278, B09J-02280, B09J-02281, B09J-02320, B09J-02328, B09J-02333, B09J-02416, B09J-02426, B09J-02429, B09J-02519, B09J-02527, B09J-02528, B09J-02530, B09J-02531, B09J-02532, B09J-02535, B09J-02539, B09J-02543, B09J-02545, B09J-02546, B09J-02547, B09J-02553, B09J-02559, B09J-02830, B09J-02831, B09J-02949, B09J-01335, B09J-01339, B09J-01344, B09J-01346, B09J-01502, B09J-01504, B09J-01505, B09J-01509, B09J-01511, B09J-01517, B09J-01521, B09J-01525, B09J-01526, B09J-01528, B09J-01672, B09J-01673, B09J-01694, B09J-01698, B09J-01096, B09J-01191, B09J-01231, B09J-01232, B09J-01236, B09J-01237, B09J-01238, B09J-01242, B09J-01249, B09J-01250, B09J-01306, B09J-01307, B09J-01308, B09J-01309, B09J-01311, B09J-01312, B09J-01314, B09J-01316, B09J-02386, B09J-02396, B09J-02448, B09J-02746, B09J-02803, B09J-02906, B09J-02917, B09J-02923, B09J-02932, B09J-01248, B09J-01305, B09J-01310, B09J-01313, B09J-01315, B09J-01320, B09J-01321, B09J-01322, B09J-01324, B09J-01325, B09J-01326, B09J-01328, B09J-01329, B09J-01330, B09J-01333, B09J-01336, B09J-01337, B09J-01340, B09J-01342, B09J-01343, B09J-01097, B09J-01240, B09J-01241, B09J-01245, B09J-01079, B09J-01332, B09J-01334, B09J-01338, B09J-01347, B09J-01503, B09J-01508, B09J-01510, B09J-01514, B09J-01522, B09J-01666, B09J-01671, B09J-02497, B09J-02631, and B09J-02647.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    Philips Heartstart FRx automated external defibrillator (AED), Model 861304
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Adresse du fabricant
    Philips Medical Systems, 2301 5th Ave Ste 200, Seattle WA 98121
  • Source
    USFDA