Events

Device Recall IntelliSpace Portal, 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
    61367
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1337-2012
  • 사례 시작날짜
    2012-02-22
  • 사례 출판 날짜
    2012-03-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-02-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107923
  • 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
    A number of non-conformances were logged for intellispace portal running software version 4.0 during in-house random verification testing. when loading a study to review, after failing to load it through add to running application the analysis application is not being closed and different (1st loaded study) patient appears in analysis (cca).
  • 조치
    Philips Healthcare sent an Urgent Medical Device Correction letter dated February 23, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the information contained in the letter with all members of their staff who need to be aware of the contents of the communication. Customers were asked to retain a copy with the equipment instruction for use. For any further information or support customers should contact their local Philips representative or local Philips Healthcare office. Customers in North America and Canada should contact the Customer Care Solutions Center at 1-800-722-9377, option 5. For questions regarding this recall call 440-483-7000.

Device

Device Recall IntelliSpace Portal,
  • 모델명 / 제조번호(시리얼번호)
    M/N 881001, Serial Numbers: 30001, 30003, 30004, 30007, 30008, 30016, 30018, 30019, 35006, 79932, 79933, 79935, 79936, 79939, 79940, 80071, 80425, 80891, 80910, 80914, 80979, 80980, 80994, 81004, 81008, 81015, 81026-81028, 81031, 81035, 81063, 81065, 81079, 81081, 81085, 81089, 81119, 81127, 81129, 81130, 81132, 81133, 81147, 81150, 81157, 81161, 81163-81165, 81169, 81172, 82004, 82006-82009, 82011, 82015-82018, 82020, 82021, 82023-82030, 85006-85011, 85025-, 5027, 85029, 85041-85043, 85046, 85049, 85053, 85067 & 85068.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AL, AR, FL, GA, IO, IN, MI, NJ, NY, OH, OK, OR, PA, SC, TN, TX & WA and the countries of Australia, Canada, China, Czech Republic, France, Germany, India, Indonesia, Israel, Italy, Poland, Spain, Sweden, Switzerland & United Kingdom
  • 제품 설명
    IntelliSpace Portal, M/N 881001, IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin- client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

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