Events

Device Recall Animas Vibe Insulin Infusion Pump 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Animas 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
    69293
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0136-2015
  • 사례 시작날짜
    2014-06-10
  • 사례 출판 날짜
    2014-10-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-09-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130182
  • 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
    unknown device name - Product Code N/A
  • 원인
    Animas determined that the hebrew language translation in the vibe insulin infusion pump was incorrect and could lead to potential patient confusion. in addition, one line of hebrew text was omitted from the display screen.
  • 조치
    A recall notification letter, dated June 2014, was sent to the recalling firm's sole customer, TriTech Biomed, in Israel, to notify them about the product, problem, and action to be taken. The distributor sent letters to their customers on July 16, 2014.

Device

Device Recall Animas Vibe Insulin Infusion Pump
  • 모델명 / 제조번호(시리얼번호)
    Model Number(s): 11220008 PMPW/OKIT,VIBE,BLU,mg,IL 11220108 PMPW/OKIT,VIBE,BLK,mg,IL 11220208 PMPW/OKIT,VIBE,SIL,mg,IL 11220408 PMPW/OKIT,VIBE,PGL,mg,IL 11220508 PMPW/OKIT,VIBE,LGN,mg,IL 11251008 REV KIT,VIBE,BLU,mg,IL 11251108 REV KIT,VIBE,BLK,mg,IL 11251208 REV KIT,VIBE,SIL,mg,IL 11251408 REV KIT,VIBE,PGL,mg,IL 11251508 REV KIT,VIBE,LGN,mg,IL 11451008 REV KIT,VIBEPL,BLU,mg,IL 11451108 REV KIT,VIBEPL,BLK,mg,IL 11451208 REV KIT,VIBEPL,SIL,mg,IL 11451408 REV KIT,VIBEPL,PGL,mg, IL 11451508 REV KIT,VIBEPL,LGN,mg,IL 11420008 PMPW/OKIT,VIBEPL,BLU,mg,IL 11420108 PMPW/OKIT,VIBEPL,BLK,mg,IL 11420208 PMPW/OKIT,VIBEPL,SIL,mg,IL 11420408 PMPW/OKIT,VIBEPL,PGL,mg,IL 11420508 PMPW/OKIT,VIBEPL,LGN,mg,IL
  • 유통
    International Distribution in Israel only.
  • 제품 설명
    Animas Vibe Insulin Infusion Pump. || This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.
  • Manufacturer
    Animas Corporation

Manufacturer

Animas Corporation
  • 제조사 주소
    Animas Corporation, 200 Lawrence Dr, West Chester PA 19380-3428
  • Source
    USFDA