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
    71228
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1682-2015
  • 사례 시작날짜
    2015-03-11
  • 사례 출판 날짜
    2015-05-28
  • 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=136871
  • 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
    It was noticed that the spectroscopy voxel map did not align with the anatomical images of the phantom. this resulted in incorrect orientation of the chemical shift imaging (csi) data.
  • 조치
    On 3/11/2015 the firm sent Urgent - Medical Device Correction letters to their customers. The letters identified the affected device, explained the reason for the recall, how to identify affected product, advice on actions to be taken by customer/user, and any actions planned by the firm. Customers were advised to use software provided by Philips to view spectroscopy images; and, not to export and view images using third party software. The firm stated that it will be issuing a software update. If further information or support concerning the issue is needed, customers are asked to contact their local Philips representative or local Philips Healthcare office.

Device

Device Recall Ingenuity TF PET/MR
  • 모델명 / 제조번호(시리얼번호)
    Serial #'s: 11005, 11006, 11007, 11008, 11009, 11010, 11011, 11012, 11013, 11014 & 24061.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, including the states of NY, OH, & TX; and, the countries of Finland, Germany, Japan, Netherlands, South Korea, Spain, & Switzerland.
  • 제품 설명
    Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 882380, Philips Medical Systems. || The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI).
  • 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