Events

ECG Cable 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Edan Instruments, 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
    59418
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0041-2012
  • 사례 시작날짜
    2010-09-10
  • 사례 출판 날짜
    2011-10-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-10-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103882
  • 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
    Electrocardiograph - Product Code DPS
  • 원인
    The 3 leads of the cable, rl, la and ll were labeled in wrong sequence. the left arm (la) is mislabeled as right leg (rl). the left leg (ll) is mislabeled as left arm (la). the right leg (rl) is mislabeled as left leg (ll). there have been no reports of injury as a result of this issue.
  • 조치
    Edan Instruments, Inc. sent an Urgent - Medical Device Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that wrongly labeled cable may lead to incorrect ECG waveforms during ECG test, customers were reminded to review previous diagnoses made from this cable to mitigate any inappropriate recordings or treatment made. Customers were instructed to replace the affected ECG Cables once they receive the new ECG Cable, and collect all the affected ECG Cables and then destroy and dispose of them according to local regulations. Questions or concerns were directed to the following numbers: Oceania and Asia: +86 (755) 2689 8322 North America, South America: +86 (755) 2689 9914 Europe: +86 (755) 2669 4684

Device

ECG Cable
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: P09100310 P09100406 P09100428
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Dominica, Ecuador, Colombia, Honduras, Peru, Mexico, El Salvador, Guatemala, Venezuela, Uruguay, Chile, Panama, Nicaragua, Ecuador, Australia, Philippines, Malaysia, Indonesia, Chinese Taipei, & Spain
  • 제품 설명
    ECG Cable Part Number: 01.57.471017 for use with the SE-1 series, SE-3 series and SE-601 series Smart Electrocardiograph || ECG cable is an accessory of the following machines: SE-1 series, SE-3 series and SE-601 series electrocardiograph (ECG). The EDAN ECG is a diagnostic and prescription device only intended to be used in hospitals or healthcare facilities by qualified doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help medical professionals to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. ECG cable is packed in plastic bag, as an accessory putting together with ECG machine in the package box.
  • Manufacturer
    Edan Instruments, Inc.

Manufacturer

Edan Instruments, Inc.
  • 제조사 주소
    Edan Instruments, Inc., 7/F, Yuehai Office Bldg., 1128 Nanyou Road, Nanshan, Shenzhen Guangdong China
  • 제조사 모회사 (2017)
    Edan Instruments, Inc.
  • Source
    USFDA