Device Recall SCOPIX LR 5200P Laser Imagers 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 AGFA Corp. 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
    27844
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0207-04
  • 사례 시작날짜
    2003-11-25
  • 사례 출판 날짜
    2003-12-11
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2004-10-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Camera, Multi Format, Radiological - Product Code LMC
  • 원인
    The gs1 circuit board may fail resulting in smoke or fire.
  • 조치
    Consignees were notified by letter on 11/25/2003. They were informed of the problem and were advised, if they have the affected type and serial number, to contact the Agfa service representative to arrange for repair. The firm intends to install a modified circuit board on each machine remaining in operation at customer locations. Consignees were instructed to discontinue use of the device immediately and to disconnect the unit from the power supply if any odor of smoke or fire is detected. They were urged to complete the Customer Acknowledgement form included with the letter and return it in the enclosed postage paid envelope.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model number LR 5200P, Catalog number: EMQT S000, Types: 8394/600, Serial numbers: 4000 through 5266.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The units were distributed to hospitals and other health facilities located nationwide
  • 제품 설명
    SCOPIX ¿ LR 5200P¿ Laser Imagers, Type 8394/600, serial numbers between 4000 and 5266.
  • Manufacturer

Manufacturer

  • 제조사 주소
    AGFA Corp., 10 S Academy St, Greenville SC 29601-2632
  • Source
    USFDA