Events

Device Recall AutoSPECT Pro Software Application 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems (Cleveland) Inc 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
    73776
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1504-2016
  • 사례 시작날짜
    2016-03-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-07-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144959
  • 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 autospect pro application was only designed to reconstruct cardiac spect data obtained with detectors positioned at 90¿ or 180¿ relative to one another. however, certain gamma cameras allow for other relative detector angles. data acquired at these other angles will not be correctly reconstructed by autospect pro and the results will likely be erroneous.
  • 조치
    On March 4, 2016, the firm sent an URGENT - Field Safety Notice Medical Device Correction letter to their customers. The letter identified the affected device, the reason for the recall, and under what circumstances the problem occurs. Customers are to contact Philips as described if they are unsure whether their gamma cameras supports the modes. The firm will implement the AutoSPECT Pro software upgrade and contact customers to schedule the appointment. If further assistance or support is needed, customers are to contact their local Philips representative.

Device

Device Recall AutoSPECT Pro Software Application
  • 모델명 / 제조번호(시리얼번호)
    M/N 882489; S/N: 66794, 66798, 66836, 66009,66011, 67154, 66828, 67058, 67050, 67031, 67284, 66332, 66335, 66397, 67026, 67040, 66084, 66089, 66092, 67007, 67011, 67226, 66956, 66454, 66447, 66413, 66129, 66128, 66300, 66023, 11728, 66000, 66938, 67270, 67252, 66571, 66443, 66324, 66869, 68477, 66682, 66815, 66284, 67263, 66265, 66277, 66880, 66892, 66258, 66079, 66181, 66451, 66627, 66187, 66806, 67016, 67008, 66706, 66745, 66817, 66822, 66910, 66908, 66811, 67087, 67094, 66241, 66825, 66632, 66624, 66854, 66689, 66690, 66906, 66792, 67173, 67069, 67166, 68290, 67182, 66785, 67292, 67286, 66768, 66769, 66550, 66113, 67220, 67193, 67186, 66657, 66668, 66564, 66065, 67065, 67208, 67204, 66818, 66819, 67122, 66818, 66819, 66456, 67212, 66019, 67057, 67172, 67157, 67167, 67162, 66737, 68361, 66183, 66368, 66387, 66376, 66415, 66136, 66137, 66960, 66958, 67142 & 67165.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, including the states of CO, DE, FL, GA, IL, IN, KS, MO, NC, NV, NY, OH, OR, PA, TN & TX; and, the countries of Australia, Austria, Belgium, Canada, China, Denmark, Egypt, France, Germany, Greece, Ireland, Israel, Italy, Lebanon, Malaysia, Saudi Arabia, Slovenia, South Africa, Switzerland, Turkey, & United Kingdom.
  • 제품 설명
    Extended Brilliance Workspace NM Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH. || Provides software applications used to process, analyze, and display medical images/data.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • 제조사 주소
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA