Events

DATEXOHMEDA TRUSAT PULSE OXIMETER 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Healthcare, 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
    57889
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3206-2011
  • 사례 시작날짜
    2011-04-08
  • 사례 출판 날짜
    2011-09-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-03-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97686
  • 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
    Pulse oximeter - Product Code DPZ
  • 원인
    The plastic enclosure on the external power supply of the trusat pulse oximeter is prone to breakage, and overheating. the issue may impact patient or user safety. potential for system or components to start on fire or explode (general case).
  • 조치
    On 4/8/11 GE Healthcare sent consignees an "Urgent Medical Device Correction" letter dated March 30, 2011. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing, Director of Biomedical Engineering & Home Healthcare Provider. The letter listed the Safety Issues, Safety Instructions, Affected Product Details, Product Correction and Contact Information.

Device

DATEXOHMEDA TRUSAT PULSE OXIMETER
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA, ZAMBIA, VIETNAM, VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, UGANDA, TURKEY, TUNISIA, TRINIDAD & Tobago, THAILAND, UNITED REPUBLIC OF TANZANIA, PROVINCE OF CHINA TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SUDAN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI ARABIA, RUSSIAN FEDERATION, ROMANIA, QATAR, PORTUGAL, POLAND, PHILIPPINES, PERU, PANAMA, OMAN, NORWAY, NICARAGUA, NEW ZEALAND, NETHERLANDS, NEPAL, MOZAMBIQUE, MEXICO, MALTA, MALAYSIA, MACEDONIA, LITHUANIA, LIBYAN ARAB JAMAHIRIYA, LEBANON, LATVIA, KUWAIT, REPUBLIC OF KOREA, KENYA, JORDAN, JAPAN, ITALY, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, HUNGARY, HONG KONG, HONDURAS, GUATEMALA, GUADELOUPE, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, KOREA, EL SALVADOR, EGYPT, ECUADOR, DENMARK, CZECH REPUBLIC, CYPRUS, CROATIA, COSTA RICA, COLOMBIA, CHINA, CHILE , CANADA, BRITISH INDIAN OCEAN TERRITORY, BRAZIL, BOLIVIA, BENNIN, BELGIUM, BANGLADESH, BAHAMAS, AUSTRIA, AUSTRALIA, ARGENTINA, and ALGERIA.
  • 제품 설명
    DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 (GE Healthcare)
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

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