Events

Device Recall UniCircuit (W Connector, Adaptor, Y piece) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Medical Systems, LLC 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
    52605
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1870-2009
  • 사례 시작날짜
    2009-06-05
  • 사례 출판 날짜
    2009-09-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-01-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83446
  • 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
    Breathing circuit - Product Code CAI
  • 원인
    Breathing circuit inner tube may separate from the rigid connectors under certain conditions. a separation of the inner tube from the connector may prevent adequate gas flow (o2, n2o and anesthetic agents) to the patient. a separation can also cause co2 re-breathing. this could lead to hypoxia and/or hypercarbia and inadequate anesthesia delivery.
  • 조치
    GE Healthcare sent consignees 6/5/09 an "Urgent Medical Device Correction" letter dated June 5, 2009. The letter was addressed to Health Care Administrator/Risk Manager; Chief of Anesthesia; Director of Clinical Engineering; Risk Manager. The letter described the Safety Issue, Affected Product Details, Safety Instructions (included "Recall Confirmation" form fax to 973-790-4150), Product Correction and Contact Information.

Device

Device Recall UniCircuit (W Connector, Adaptor, Y piece)
  • 모델명 / 제조번호(시리얼번호)
    This correction pertains to Uni-Circuits from lot# 084812 and later, up to and including lot# 092210
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA, AUSTRALIA, DENMARK, FRANCE, ESTONIA, GERMANY, ITALY, JORDAN, NETHERLANDS, NORWAY, SWEDEN, and UNITED ARAB EMIRATES.
  • 제품 설명
    GE Healthcare, Uni-Circuit Kit, Adult, Disposable, 1.8 m/72 in, REF M1089028, M1087972, M1087975, M1126445, M1127508, M1127509, M1129780, || M1129781, M1130230, M1137805, M1137199, M1145542, M1170604, M1151662, || M1152224, M1158990, M1100486, M1122080, M1126444, M1163003, M1163255 || M1132533, M1133966, M1170051, M1135144, M1139485, M1118627, M1118628, || M1145406, M1147298, M1137811, M1152651, M1160275. pkg of 20 pcs, Latex Free. Breathing circuit for use with anesthesia machine or ventilator.
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

GE Medical Systems, LLC
  • 제조사 주소
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA