Events

Device Recall GE Healthcare Discovery IGS 730 Cardiovascular XRay Imaging System 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
    66168
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2253-2013
  • 사례 시작날짜
    2013-06-19
  • 사례 출판 날짜
    2013-09-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-10-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121602
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • 원인
    Ge healthcare has recently become aware of a potential safety issue with respect to discovery igs 730 imaging systems. a patient data management error may prevent the discovery igs 730 imaging system from booting on start-up or re-booting during procedure. the boot issue may occur when a large amount of patient data remains in the browser and is not deleted. the inability to boot the system ma.
  • 조치
    The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated June 19, 2013 to its Consignees/customers. The letter described the Safety Issue, Safely Instructions, Affected Product Detail, Product Correction and Contact Information. The consignees were instructed to please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions. GE Healthcare will correct all affected systems at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please call : United States: 800 437 1171. For other countries, please contact your local GE Healthcare Service Representative.

Device

Device Recall GE Healthcare Discovery IGS 730 Cardiovascular XRay Imaging System
  • 모델명 / 제조번호(시리얼번호)
    Mfg Lot or Serial # 00000611882BU2 00000612803BU7 00000613979BU4 00000620447BU3
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: US (nationwide) including states of : PA and TN; countries of: FRANCE and SINGAPORE.
  • 제품 설명
    GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. || The angiography X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image guided surgical procedures. The OR table is suitable for interventional and surgical procedures.
  • 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