Events

Device Recall Ingenuity TF PET/MR 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
    71882
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2491-2015
  • 사례 시작날짜
    2015-07-23
  • 사례 출판 날짜
    2015-08-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-06-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139267
  • 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
    Tomographic imager combining emission computed tomography with nuclear magnetic resonance - Product Code OUO
  • 원인
    Philips healthcare has become aware of a problem in which the ingenuity tf pet/mr pet reconstruction server (prs) database may lock up after an mr acquisition is completed and before a pet acquisition is begun, even though no actual database lockup issue has been reported in the field-installed ingenuity tf pet/mr systems.
  • 조치
    On July 23, 2015 the firm sent Field Safety Notices to their customers.

Device

Device Recall Ingenuity TF PET/MR
  • 모델명 / 제조번호(시리얼번호)
    M/N 882380; S/N: 11005, 11006, 11007, 11008, 11009, 11010, 11011, 11012, 11013, 11014 & 24061.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was shipped to the following states: NY, OH & TX. Product was also shipped to the following countries: Finland, Germany, Hong Kong, Japan, Netherlands, South Korea, Spain & Switzerland.
  • 제품 설명
    Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
  • 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