Events

RITA StarBurstMRI SemiFlex 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Rita Medical Systems, Inc. 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
    37742
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0754-2007
  • 사례 시작날짜
    2007-04-03
  • 사례 출판 날짜
    2007-04-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-01-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51445
  • 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
    Electro-surgical Device - Product Code GEI
  • 원인
    The product may have a cracked tray which can compromise the sterility of the product.
  • 조치
    Notification by letter of the AngioDynamics, Inc. sales force and the domestic and international distributors began on April 2, 2007. They were asked to return all affected devices to the Manchester, GA division of AngioDynamics, Inc. A reply form was attached to be completed and returned via fax to AngioDynamics.

Device

RITA StarBurstMRI SemiFlex
  • 모델명 / 제조번호(시리얼번호)
    Part number: 700-102615, Lot number: 22445, 24657, 24772, 24557, 24824, 24921, 25126, 25360, 25361, 25431, 25432, 25554, 25601, 25555, 25644, 25755, 25645, 25756, 25815, 25816, 25860, 25859, 25947, 25948, 26153, 26239, 26312, 26466, 25977, 25978, 26240, 26311, 26467, 26564, 26580, 26587, 26588, 26672, 26673, 26730, 26940, 26941, 26994, 27071, 27165, 27179, 27256, 27358, 27408, 27407, 27409, 27444, 27562, 27594, 27719, 27720, 27811, 27875, 27877, 27961, 27962, 27968, 28091, 28098, 28257, 28322, 28440, 28441, 28468, 28525, 28526, 28560, 28638, 28714, 28639, 28719, 28906, 28881, 28971, 28972, 29044, 29113, 29158, 29159, 29256, 29340, 29548, 29045, 29667, 29856 & 29969
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide, including USA, Austria, Canada, Croatia, Denmark, Egypt, Estonia, France, Finland, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Latvia, Netherlands, Norway, Poland, Republic of Ireland, Romania, Russia, Saudi Arabia, Singapore, Solomon Islands, South Africa, Spain, Switzerland, UK, and United Arab Emirates.
  • 제품 설명
    RITA¿ Starburst¿ MRI SemiFlex (3-5 cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RITA Medical Systems, Inc., One Horizon Way, Manchester, GA 31816
  • Manufacturer
    Rita Medical Systems, Inc.

Manufacturer

Rita Medical Systems, Inc.
  • 제조사 주소
    Rita Medical Systems, Inc., 1 Horizon Way, Manchester GA 31816-1749
  • Source
    USFDA