Events

Device Recall DXD 600 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 AGFA Healthcare 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
    68752
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2175-2014
  • 사례 시작날짜
    2014-07-02
  • 사례 출판 날짜
    2014-08-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-06-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128600
  • 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
    System, x-ray, stationary - Product Code KPR
  • 원인
    Some customers reported that while using the dx-d600 in room or exam preparation, the overhead tube crane (otc) showed increased velocity and uncontrolled longitudinal movement.
  • 조치
    AGFA HealthCare sent an URGENT FIELD SAFETY NOTICE letter dated July 2, 2014 to affected customers. The letter described the affected product, problem and actions to be taken. Customers were instructed to complete and return the Acknowledgment form, via FAX-Back or email. A Mandatory Service Bulletin DIS012.14E/No. 32, was released June 30, 2014, to implement the mandatory upgrade of full automatic DX-D600 systems to version 3.6 to prevent unexpected system movements. This Mandatory Service Bulletin was issued to Agfa DR Specialists to perform the service. A 2nd release will be implemented to upgrade semi-automatic systems. For questions contact your local AGFA HealthCare organization 1-877-777-2432.

Device

Device Recall DXD 600
  • 모델명 / 제조번호(시리얼번호)
    Serial Nos. A5430000089, A5430000131, A5430000015, A5430000095, A5430000052, A5430000061, A5430000079, A5430000030, A5430000042, A5430000066, A5430000081, A5430000085, A5430000096, A5430000020, A5430000067, A5430000125, A5430000105
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Natinwide in the state of GA, IN, KS, KY, MA, NJ, SC, VA, DC and the country of Canada
  • 제품 설명
    DX-D 600 - DXD Imaging Package || Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities, check abdomen and other both parts.
  • Manufacturer
    AGFA Healthcare Corp.

Manufacturer

AGFA Healthcare Corp.
  • 제조사 주소
    AGFA Healthcare Corp., 10 S Academy St, Greenville SC 29601-2632
  • 제조사 모회사 (2017)
    Agfa-Gevaert NV
  • Source
    USFDA