Events

Device Recall Brightview XCT, 3/8" 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
    58323
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2155-2011
  • 사례 시작날짜
    2011-03-28
  • 사례 출판 날짜
    2011-05-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-06-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98985
  • 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, tomography, computed, emission - Product Code KPS
  • 원인
    The current headholder to support bright view xct brain imaging allowed for imaging the brain but doe allow for imaging of the associated shoulder/neck area of the body.
  • 조치
    Customer information sheets will be provided to all customers when the field change order commences in April 2011. Philips will implement a full change order for the installation of the new headholder to replace the old headholder, free of charge, to all affected Philips BrightView XCT SPECT/CT units. For questions regarding this recall call 408-463-3000.

Device

Device Recall Brightview XCT, 3/8"
  • 모델명 / 제조번호(시리얼번호)
    Model number: 4535-607-49161, catalog number 882482; Serial numbers: 6000150 6000114 6000106 6000071 6000107 6000139 6000138 6000131 6000130 6000128 6000126 6000125 6000123 6000121 6000163 6000156 6000151 6000147 6000145 6000144 6000141 6000120 6000119 6000118 6000109 6000105 6000104 6000103 6000102 6000099 6000098 6000097 6000096 6000088 6000085 6000080 6000077 6000067 6000066 6000041 6000015 6000012 6000010 6000005 6000084 6000074 6000072 6000070 6000065.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including US distribution to OH, MA, FL, VT and KY and the countries of Norway, Saudi Arabia, Belgium, Brazil, Japan, China, Poland, Austria, United Kingdom, Spain, Indonesia, Malaysia, Taiwan, Germany, United Arab Emirates, Netherland, Switzerland, Ireland, Czech Republic and Canada.
  • 제품 설명
    Brightview XCT, 3/8" || Philips Medical Systems || Brightview XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrated with an attenuation device consisting of flat panel x-ray imaging components. Brightview ECT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction.
  • 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