Device Recall Medstorm Adult Radiolucent Electrode 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Heart Sync, 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
    57736
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1371-2011
  • 사례 시작날짜
    2010-12-17
  • 사례 출판 날짜
    2011-02-18
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-07-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Electrode, electrocardiograph, multi-function - Product Code MLN
  • 원인
    The seal on the electrode pouch may be open, exposing the electrode to the outside environment. the package does have a caution statement that states, " do not open package until immediately prior to using electrodes. and electrodes may dry out when removed from packaging and exposed to air.
  • 조치
    Heart Sync, Inc sent an URGENT MEDICAL DEVICE RECALL letter dated December 23, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Examine their inventory and quarantine product that was subject to the recall that was not sealed properly. Contact any customers if they further distributed the product and notify them at once of this product recall. Contact the firm if they had any unused product. The firm would issue a UPS Call Tag to have the product returned to them and the firm would send replacement product as soon as they were notified. Complete and return the Recall Return Response Form to the firm in the attached prepaid envelope. For any questions regarding this recall call 734-213-5530.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot Y-032709
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AK, AZ, CA, FL, IL, KS, LA, MA, ND, NM, OH, TX, WA, WI and WV; and Canada
  • 제품 설명
    Medstorm Adult Radiolucent Electrode  Philips Medical , Part #16250, HeartSync Ann Arbor, MI. || The Adult Radiolucent Multifunction Tin Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous cardiac pacemaker and the patients skin. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the respective low power mono-phasic or bi-phasic defibrillator (360 joules maximum) or external pacemaker.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Heart Sync, Inc, 5643 Plymouth Rd, Ann Arbor MI 48105-9586
  • 제조사 모회사 (2017)
  • Source
    USFDA