Events

Device Recall Powerheart AED G3 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cardiac Science Corporation 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
    34685
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0623-06
  • 사례 시작날짜
    2006-01-27
  • 사례 출판 날짜
    2006-03-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-06-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44470
  • 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 powerheart aed model 9300a may contain a suspect electronic component and there is a remote likelihood that the function of this device may be interrupted during the charge.
  • 조치
    Affected consignees were notified via telephone. If no phone contact could be made, a Urgent: Medical Device Recall letter dated 02/02/06 was sent with return receipt requested. Customers were asked to locate affected devices and remove them from service. A new AED would be sent to the customers and the customers are asked to return the affected device.

Device

Device Recall Powerheart AED G3
  • 모델명 / 제조번호(시리얼번호)
    serial numbers 4000002, 4000004, 4000006, 4000007, 4000009, 4000010, 4000011, 4000013, 4000014, 4000016, 4000018, 4000019, 4000021 thru 4000024, 4000030, 4000031, 4000034, 4000040, 4000044, 4000045, 4000047, 4000048, 4000050, 4000051, 4000054, 4000057, 4000060, 4000063, 4000064, 4000065, 4000067, 4000072, 4000075, 4000079, 4000080, 4000082, 4000085, 4000086, 4000089, 4000090, 4000095, 4000097, 4000098, 4000099, 4000136, 4000138, 4000140, 4000145, 4000156, 4000162, 4000164, 4000179, 4000184, 4000186, 4000187, 4000192, 4000209, 4000215, 4000227, 4000229, 4000230, 4000232, 4000247, 4000249, 4000250, 4000255, 4000256, 4000264, 4000271, 4000274, 4000287, 4000288, 4000291, 4000295, 4000305, 4000306, 4000314, 4000322, 4000323, 4000324, 4000326, 4000330 thru 4000335, 4000337, 4000342.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    58 customers within the US: AZ, CA, CO, DC,FL, GA, Nationwide, Hungary and Singapore. IL, IN, KS, KY, LA, MI, MO, NC, NV, NY, OH, OK, PA, SC, TN, TX, WA, WI. 2 customers OUS to include: Hungary and Singapore.
  • 제품 설명
    Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982.
  • Manufacturer
    Cardiac Science Corporation

Manufacturer

Cardiac Science Corporation
  • 제조사 주소
    Cardiac Science Corporation, 3303 Monte Villa Pkwy, Bothell WA 98021
  • Source
    USFDA