Events

Device Recall Heartstart 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    53816
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1193-2010
  • 사례 시작날짜
    2009-11-02
  • 사례 출판 날짜
    2010-03-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-05-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86576
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Automated External Defibrillators (Non-Wearable) - Product Code MKJ
  • 원인
    Potential for failure of a capacitor during use which would prevent the aed from delivering effective defibrillation therapy when indicated.
  • 조치
    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
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution.
  • 제품 설명
    Philips Heartstart FRx automated external defibrillator (AED), Model 861304
  • Manufacturer
    Philips Medical Systems

Manufacturer

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