Events

Device Recall IVC 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Invacare 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
    26479
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0174-04
  • 사례 시작날짜
    2003-06-09
  • 사례 출판 날짜
    2004-07-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-05-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27751
  • 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
    Bed, Therapeutic, Ac-Powered, Adjustable Home-Use - Product Code LLI
  • 원인
    Pull tube on bed may bend or separate causing inoperability of bed or head section to fall.
  • 조치
    The firm began telephoning direct consignees on 6/9/03 and also began sending recall letters to these consignees on 6/9/03. The letter provides a list of affected units shipped to the consignee and the serial number of the affected foot section on the bed. If the consignee indicated they wanted to perform the correction themselves then the indicated number of corrective bracket installation kits are being sent. Also they are given the option of having an Invacare authorized service center perform the correction. This is for units in their possession and also at patient homes. As of October 2003 enough corrective kits have been forwarded to dealers to correct all involved units.

Device

Device Recall IVC
  • 모델명 / 제조번호(시리얼번호)
    Foot section model numbers and serial number ranges: Model # Beginning S/N Ending S/N 5490IVC 03D891256 03E035155 5890IVC 03D889942 03E002241 5491IVC 03E969254 03E433379 5891IVC 03E970154 03E971163  Bed Models that include the recalled food sections: 5310IVC, 5311IVC, 5410IVC, 5411IVC  Bed package model numbers which include the affected Beds and foot sections:  BED-21VC, BED-4IVC, BED-9IVC, BED-10IVC, BED-19IVC, BED-21IVC, BED-22IVC, BED-23IVC, BED-24IVC, BED-25IVC, BED-26IVC, BED-27IVC, BED-28IVC, BED-29IVC, BED-32IVC, BED-33IVC, BED-34IVC, BED-35IVC, BED-36IVC, BED-37IVC, CBED-2IVC, CBED-4IVC, CBED-4BIVC, CBED-11IVC, CBED-11BIVC, CBED-12IVC, CBED-12BIVC, CBED-19IVC, CBED-22IVC, CBED-23IVC, CBED-26IVC, CBED-28IVC.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    involved products were distributed to approximately 1100 dealers in the United Stated and to 54 Canadian dealer accounts.
  • 제품 설명
    Invacare IVC Home Care Bed (Foot Section with new head actuator from Linak.
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • 제조사 주소
    Invacare Corporation, One Invacare Way, Elyria OH 44036
  • Source
    USFDA