Events

OPTIMA XR200AMX X-RAY SYSTEM - MAIN UNIT 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE) 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
    27252
  • 사례 위험등급
    III
  • 사례 시작날짜
    2012-10-10
  • 사례 국가
    Canada
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • 데이터 추가 비고
  • 원인
    There is a potential for the system to have a technique accuracy issue which is greater than the 10% specified per the product documentation. if the user rapidly increases or decreases the mas or kv on the display the technique displayed may be one renard step off or one kv increment off from what the actual exposure delivered will be. this will only occur if the technique is adjusted more than three selections. if the user adjusts the techniques again after this rapid selection prior to exposure the display of the techniques and the actual delivered technique will be the same. these situations are not compliant with iec 60601-2-54 clause 203.6.4.3.104.6.

Device

OPTIMA XR200AMX X-RAY SYSTEM - MAIN UNIT
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 5555000-4 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 5555000-3 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 5555000-6 (Lot serial: 00001027061WK9); Model Catalog: 5555000-5 (Lot serial: 00001027300WK1); Model Catalog: 5555000-5 (Lot serial: 00001027061WK9); Model Catalog: 5555000-6 (Lot serial: 00001028024WK6); Model Catalog: 5555000-5 (Lot serial: 00001028024WK6); Model Catalog: 5555000-6 (Lot serial: 00001027195WK5); Model Catalog: 5555000-5 (Lot serial: 00001027195WK5); Model Catalog: 5555000-6 (Lot serial: 00001027893WK5); Model Catalog: 5555000-5 (Lot serial: 00001027893WK5); Model Catalog: 5555000-6 (Lot serial: 00001027826WK5); Model Catalog: 5555000-5 (Lot serial: 00001027826WK5); Model Catalog: 5555000-6 (Lot serial: 00001027346WK4); Model Catalog: 5555000-5 (Lot serial: 00001027346WK4); Model Catalog: 5555000-6 (Lot serial: 00001027263WK1); Model Catalog: 5555000-5 (Lot serial: 00001027263WK1); Model Catalog: 5555000-6 (Lot serial: 00001027300WK1); Model
  • 제품 설명
    OPTIMA XR200AMX X-RAY SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)