Events

Device Recall Power Heart 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cardiac Science, Inc. 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
    29024
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1034-04
  • 사례 시작날짜
    2004-05-24
  • 사례 출판 날짜
    2004-07-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2005-11-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33195
  • 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
    Some of the high voltage capacitors in the recalled external defibrillators have had extended charge times resulting in self-test failures following which the defibrillator cannot be used/cannot be turn on.
  • 조치
    A recall letter, dated May 24, 2004, stated that a replacement AED is enclosed with the letter, and instructed consignees to replace their AED with the new one immediately and return the old AED.

Device

Device Recall Power Heart
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers of the recalled Model 9200 RD and Model 9210 RD AEDs are: 300122,300226, 300450, 300672, 300855, 301848, 303845, 304550, 305544, 306004, 306420, 306426, 306474, 306500, 306572, 306585, 306586, 306615, 306663, 306685, 306691 through 306810, 307433, 308131 through 308530, 308839, 309180, 309218, 309236, 309426, 309438, 309561, 309691 through 309894, 309897, 309903 through 309908, 309913, 309915, 309917, 309922, 309924, 309929, 309930, 309944, 309959, 309971 through 310170, 310181, 310411 through 310490, 310571 through 310610, 310691 through 311170, 311211 through 312170, 312211 through 312290, 312651 through 316050, 316518, 316691 through 316730, 316853, 316862, 316949, 316961, 316964, 316973, 317056, 317058, 317106, 317123, 317131, 317180, 317183, 317185, 317189, 317191, 317207, 317266, 317270, 317278, 318171 ¿ 318190, 318211 through 318330, 318347, 318371 through 318410, 318419, 318424, 318427, 318433, 318435, 318439, 318446, 320691 through 320930, and the following individual serial numbers separated by commas: 268231-02-35, 74414-1602, 74414-0213, 74777-0802, 75180-0246, 75180-0189, 75180-0088, 75180-0045, 75180-0608, 75180-0241, 75180-0083, 75180-0059, 75180-0123, 75180-0097, 75180-0040, 75180-0103, 75180-0109, 75180-0096, 75180-0060, 75180-0090, 75180-0091, 75180-0114, 75180-0100, 75180-0046, 75180-0047, 75180-1866, 75180-0111, 75180-0048, 75180-0085, 75180-0057, 75180-0073, 75180-0113, 75180-0237, 75180-0086, 75180-0239, 75180-0225, 75180-0606, 75180-0226, 75180-0980, 75180-0099, 75180-0061, 75180-0041, 75180-0112, 75180-0094, 75180-0076, 75180-0107, 75180-0002, 75180-1000, 75180-0049, 75180-0101, 75180-0079, 75180-0400, 75180-0607, 75180-0102, 75180-0058, 75180-0106, 75180-0062, 75180-0120, 75180-0069, 75180-0082, 75180-0072, 75180-0039, 75180-0121, 75180-0071, 75180-0074, 75180-0117l, 75180-0037, 75180-0240, 75180-0119, 75180-0063, 75180-0050, 75180-0238, 75180-0108, 75180-0093, 75180-0077, 75180-0087, 75180-0236, 75180-0067, 75180-0065, 75180-0056, 75180-0095, 75180-0105, 75180-0110, 75180-0044, 75180-0122, 75180-0115, 75180-0092, 75180-0075, 75180-0068, 75180-0084, 75180-0104, 75180-0080, 75180-0098, 75180-0118, 75180-0116, 75180-0244, 75180-0081, 75180-0078, 75180-0070, 75180-0042, 75180-0089, 75180-0064, and 75180-0043
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    The recalled AED units were distributed nationwide in the United States and to foreign accounts in Europe, Asia, Latin America, the Middle East, and Africa.
  • 제품 설명
    Power Heart Automatic External Defibrillator, Model 9210 RD
  • Manufacturer
    Cardiac Science, Inc.

Manufacturer

Cardiac Science, Inc.
  • 제조사 주소
    Cardiac Science, Inc., 5474 Feltl Rd., Minneapolis MN 55343-7982
  • Source
    USFDA