Events

Device Recall Ingenuity Core128 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
    67763
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1464-2014
  • 사례 시작날짜
    2014-03-06
  • 사례 출판 날짜
    2014-04-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-11-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126256
  • 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 customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions would intermittently not complete.
  • 조치
    .The firm, Phillips, sent an " URGENT ¿¿ Medical Device Correction" letter dated 2013 March 06, to its costumers . The letter disc ribes the product, problem and actions to be taken. The costumers were instructed to Verify that all planned image reconstructions are completed, and Perform off-line reconstructions if expected images are missing. The firm will release A Field Change Order (FCO) to correct the issue with software version release 3.5.7.and A Philips Field Service Engineer will contact you to schedule the software installation at your site. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, Option 5: Enter Site ID or follow the prompts).

Device

Device Recall Ingenuity Core128
  • 모델명 / 제조번호(시리얼번호)
    System code: 728323; Serial #: 320002, 320003, 320004, 320005, 320006, 320007, 320008, 320009, 320010, 320011, 320013, 320014, 320015, 320017, 320018, 320019, 320020, 320022, 320023, 320024, 320025, 320026, 320027, 320028, 320029, 320031, 320032, 320034, 320035, 320036, 320037, 320038, 320039, 320040, 320041, 320043, 320044, 320045, 320046, 320047, 320048, 320049, 320050, 320051, 320052, 320053, 320054, 320055, 320056, 320057, 320059, 320060, 320062, 320063, 320064, 320065, 320066, 320067, 320068, 320069, 320070, 320071, 320072, 320074, 320075, 320078, 320079, 320080, 320081, 320082, 320083, 320084, 320085, 320086, 320087, 320088, 320089, 320090, 320092, 320093, 320095, 320096, 320097, 320098, 320099, 320101, 320102, 320103, 320104, 320105,320106, 320107, 320109, 320110, 320111, 320112, 320114, 320115, 320116, 320117, 320118, 320119, 320120, 320121, 320122, 336013 & 336015.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution:US ( Nationwide) Including stages of MI, OR, PA, TX & WV; and Countries of: Australia, Bangladesh, Belgium, Brazil, Bulgaria, China, France, Germany, India, Indonesia, Ireland, Japan, Nicaragua, Oman, Palestine, Russia, South Korea, Spain, Switzerland, Thailand, Turkey & United Kingdom.
  • 제품 설명
    Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.
  • 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