Events

Device Recall Integra 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Integra LifeSciences Corp. 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
    68519
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1976-2014
  • 사례 시작날짜
    2014-06-11
  • 사례 출판 날짜
    2014-07-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-12-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128129
  • 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
    Headlamp, operating, battery-operated - Product Code HPP
  • 원인
    Led battery chargers may prematurely fail and will not charge the led battery as intended.
  • 조치
    Integra initiated a voluntary recall on June 11, 2014 to consignees that have been shipped affected product lots of Integra¿ LED Battery Chargers, Catalogue No. 90523. The written notifications were delivered to US consignees by traceable courier service and non-US consignees by traceable email or facsimile. The consignee notification: Advises them of the nature of the issue and the potential for an adverse patient consequence. Advises them to review their inventory and how to determine if they have affected battery chargers. Advises them to immediately stop the use or distribution of any affected product lot numbers they may have. Requests they identify and report to Integra if they do or do not have any unexpired affected product lots. Advises them replacements battery chargers will be shipped for any affected products they affirm are in their possession and how to return their affected product. Questions regarding these instructions, please contact Integra Customer Service at 1-800-431-1123 or your Integra sales

Device

Device Recall Integra
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers:  IE123610, IE123710, IE123810, IE123910, IE124010, IE124110, IE124210, IE124310, IE124410, IE124510, IE124610, IE124710, IE124810, IE124910, IE125010, IE125110, IE125210, IE130110, IE130210, IE130310, IE130410, IE130510, IE130610, IE130710, IE130810, IE130910, IE131010
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide and the countries of Canada, Australia, Arab Emirates, Denmark, Germany, Great Britain, India, Ireland, Israel, Japan, Kuwait, Lebanon, Malta., Netherlands, Panama, Poland, Saudi Arabia, Singapore, South Africa, Spain, Sweden, and Tunisia.
  • 제품 설명
    Integra¿ LED Battery Charger, Single Bay. || Product Number: 90523 || The LED Headlight System Battery Charger (90523) is an accessory to the LED Headlight System: || 90520US - LED Headlight w/Battery & AC/DC Power Supply - US || 90520EU - LED Headlight w/Battery & AC/DC Power Supply - EU || 90520UK - LED Headlight w/Battery & AC/DC Power Supply - UK || 90520AU - LED Headlight w/Battery & AC/DC Power Supply - AU || Product Usage: The Integra LED Headlight System Is designed to provide illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.