Events

GE ApexPro Oximeter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 General Electric Medical Systems Information Technology 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
    53980
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0631-2010
  • 사례 출판 날짜
    2010-01-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86981
  • 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
    oximeter - Product Code DQA
  • 원인
    Potential misuse of the apexpro telemetry system and incorrect message and alarm information in the apexpro operator's manual may impact patient safety. when apexpro telemetry systems are used with spo2 oximeters: 1. apexpro fh transceiver can operate with the apexpro fh xpod connected, but without ecg lead wires attached to the transceiver. this is unintended use of the device that is not do.
  • 조치
    Consignees were sent on 10/27/09 a GE Healthcare "Urgent Medical Device Correction" letter dated September 25, 2009. The letter was addressed to Risk Manger, Chief of Nursing, director of Biomedical Engineering. The letter described the Safety Issues, Affected Product Details, Product Correction, Safety Instructions and Contact Information. "ApexPro Telemetry System Operator's Manual Supplement for SpO2 was enclosed with the letter.

Device

GE ApexPro Oximeter
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA, AUSTRALIA, AUSTRIA, BELGIUM, BERMUDA, CANADA, CHILE, CHINA, COSTA RICA, CROATIA, CUBA, CYPRUS, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUAM, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LEBANON, MALAYSIA, MALTA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PHILIPPINES, POLAND, QATAR, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, and VENEZUELA.
  • 제품 설명
    GE ApexPro Oximeter systems (ApexPro CH or ApexPro FH with ApexPro Telemetry version 3.9 software)
  • Manufacturer
    General Electric Medical Systems Information Technology

Manufacturer

General Electric Medical Systems Information Technology
  • 제조사 주소
    General Electric Medical Systems Information Technology, 8200 W Tower Ave, Milwaukee WI 53223
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA