Events

Cuffable Blood Pressure Cuffs 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Healthcare, LLC 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
    58854
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2581-2011
  • 사례 시작날짜
    2011-04-26
  • 사례 출판 날짜
    2011-06-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-05-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100421
  • 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
    Blood Pressure Cuffs - Product Code DXQ
  • 원인
    Bp cuffs may not properly inflate due to a leak.
  • 조치
    GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated April 26, 2011 to all affected customers. The letter identified the product, the problem and the action to be taken. Customers were instructed to discontinue use of the product, isolate all affected products, return only unused products and distribute this letter to any other healthcare institutions that are potentially affected by this issue. The letter asks that each customer complete and return the enclosed confirmation form via fax to 800-535-7923, in order to confirm receipt of the notification letter. For any questions, contact your local Vital Signs Account Manager or the International Customer Service at 1-800-932-0760.

Device

Cuffable Blood Pressure Cuffs
  • 모델명 / 제조번호(시리얼번호)
    510(k) K911213 Medical Device Listing Number D110124 for year 2009- Lot #2689- Lot #3659 For year 2010 - Lot #0010-Lot #2530
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide) including Puerto Rico and countries of: Argentina, Australia, Belgium, Canada, Chile, Ecuador, Finland, Germany, Hong Kong, Israel, Italy, Latvia, Lebanon, Nicaragua, Panama, Peru, Saudi Arabia, Slovenia, UK, Uruguay and Venezuela
  • 제품 설명
    Cuffable Blood Pressure Cuffs; Manufactured for Vital Signs, Inc., a GE Healthcare Company 20 Campus Road, Totowa, NJ 07512 Made in Mexico. || The cuff is used to determine a subject's blood pressure.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • 제조사 주소
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA