Events

SKYLight Gamma Camera 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems 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
    57029
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0398-2011
  • 사례 시작날짜
    2010-10-15
  • 사례 출판 날짜
    2010-11-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95212
  • 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
    Emission Computed Tomography System - Product Code KPS
  • 원인
    Detector arm assembly may slide to hardware limit, potentially causing impact.
  • 조치
    Firm will notify consignees via Urgent - Medical Device Correction, dated Nov 3, 2010, via FedEx. The letter identified the affected product, described the problem, the hazard involved, how to identify affected products, actions to be taken, and actions planned by Philips. Customers are to contact their Field Safety Engineer immediately to schedule an inspection of their system. If customers suspect that the identified problem has occurred with their device, they should immediately stop using the system until Philips has confirmed it as safe to use. If customers need further information concerning this issue, they are to contact their local Philips representative.

Device

SKYLight Gamma Camera
  • 모델명 / 제조번호(시리얼번호)
    3/8" SPECT, Model number 4535 600 66661, and 5/8 SPECT, Model number 4535 602 20381, all units manufactured between July 2001 to August 2003.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA and the Netherlands.
  • 제품 설명
    SKYLight Gamma Camera Gearbox brake, a component of the SKYLight Gamma Cameras 3/8" SPECT, Model number 4535 600 66661; and 5/8" SPECT, Model number 4535 602 20381, manufactured by Philips Medical Systems (Cleveland), Cleveland OH. || Intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • 제조사 주소
    Philips Medical Systems, 3860 N 1st St, San Jose CA 95134-1702
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA