Events

Device Recall Integra 3 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 RESEARCH INSTRUMENTS LTD - SITE B 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
    73581
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1584-2016
  • 사례 시작날짜
    2016-03-11
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144524
  • 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
    Micromanipulators and microinjectors, assisted reproduction - Product Code MQJ
  • 원인
    The units have been fitted with a potentially faulty power supply cable.
  • 조치
    Research Instruments sent a recall notification dated 03/11/2016, via UPS with confirmed delivery receipt, to all affected customers. The letter identified the affected product, problem and the action needed to be taken by the customer. The letter asked customers to contact Research Instruments First Line Support if they had any questions.

Device

Device Recall Integra 3
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: 2-381
  • 의료기기 분류등급
    Obstetrical and Gynecological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the states of: MA, NY and countries of : Algeria, Australia, Austria, Bahrain, Belgium, British Virgin Islands, Bulgaria, Canada, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Nigeria, Norway, Pakistan, Peru, Poland, Romania, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Taiwan, Thailand, Tunisia, Turkey, UAE, Ukraine, United Kingdom, and Vietnam,
  • 제품 설명
    Integra 3; Model Numbers: 6-54-100, 6-54-110, 6-54-150, 6-54-160 || Product Usage: || The Rl TDU500 Micromanipulator for Assisted Reproduction is used to accurately position microtools under a microscope for the techniques of Assisted Reproduction. The Rl Integra is a configuration comprising two TDU500 micromanipulators, two air syringes and temperature control system within a single housing.
  • Manufacturer
    RESEARCH INSTRUMENTS LTD - SITE B

Manufacturer

RESEARCH INSTRUMENTS LTD - SITE B
  • 제조사 주소
    RESEARCH INSTRUMENTS LTD - SITE B, Bickland Ind. Park, Falmouth United Kingdom
  • Source
    USFDA