Events

Device Recall automated external defibrillator 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
    53383
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0062-2010
  • 사례 시작날짜
    2009-10-01
  • 사례 출판 날짜
    2009-12-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-09-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85733
  • 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
    A potential exists for a component failure, which, if it occurs, could result in the inability to deliver therapy.
  • 조치
    On September 28, 2009 Philips issued a nationwide press release. On October 1, 2009 the firm issued notification letters to consignees arranging for the return and replacement of the affected units. The firm also set up a page on their website with a serial number look-up tool. For further information or support concerning this issue, customers are asked to contact Philips at 1.800.263.3342 or visit www.philips.com/FR2PlusAction for the serial number look-up list, answers to frequently asked questions, directions for the battery insertion test, and the replacement AED selection form.

Device

Device Recall automated external defibrillator
  • 모델명 / 제조번호(시리얼번호)
    The following letter codes are used in conjunction with the catalog numbers to indicate language of Instructions for Use (IFU) and FR2+ voice prompts: ABA=U.S. English; ABU=U.K. English; ABD=German; ABE=Spanish; ABF=French; ABH=Dutch; ABI=Hong Kong; ABJ=Japanese; ABN=Norwegian; ABO=Taiwanese; ABS=Swedish; ABX=Finland; ABZ=Italian; AB2=China; and  AC4=Portugal.  Additional (non-language related) letter codes for product: A01=Product with TSO (Technical Standard Order) approved battery; and RF=Service Replacement.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Domestic and Worldwide distribution to: United States, Canada, Australia, Austria, Bulgaria, China, Finland, France, Germany, Gibraltar, Great Britain, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Jordan, Lebanon, Malaysia, Mexico, Netherlands, Norway, Portugal, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Arab Emirates.
  • 제품 설명
    Heartstart FR2+ automated external defibrillator models M3861A and M3841A are NOT equipped with the ECG Module. || Model M3861A is under the Philips label and M3841A is under the Laerdal label.
  • Manufacturer
    Philips Medical Systems

Manufacturer

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