Events

Device Recall Digital Diagnost Rel 3 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Healthcare 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
    60323
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0313-2012
  • 사례 시작날짜
    2011-11-01
  • 사례 출판 날짜
    2011-11-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-01-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105032
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • 원인
    Missing a small, metal protective cover on the bottom side of the control handle for the ceiling suspension. exposes printed circuit.
  • 조치
    The firm, Philips Healthcare, sent a "URGENT - Field Safety Notice" letter dated October 25, 2011, to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed: Do not place your hand in the open slot below the Control Handle and ensure that no patient places his/her hands the opening; review the following information with all members of their staff who need to be aware of the contents of this communication, and retain a copy with the equipment instruction for use. Philips has issued a Field Change order instructing Service Engineers to check affected systems and install the cover where it is missing free of charge. If you need any further information or support concerning this issue call 978-659-4519.

Device

Device Recall Digital Diagnost Rel 3
  • 모델명 / 제조번호(시리얼번호)
    S/N:  SN11000009 SN11000012 SN11000014 SN11000015 SN11000016 SN11000017 SN11000025 SN11000029 SN11000013 SN11000020 SN11000022 SN11000005 SN11000008 SN11000010 SN11000003 SN11000019 SN11000034 SN11000004 SN11000018 SN11000023 SN11000024 SN11000006 SN11000007 SN11000011 SN11000026 SN11000027 SN11000028 SN11000002
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) including states of: NC, SC, TX, and WV; and countries of: Australia, Austria,Canada, Germany, Italy, Netherlands, Sweden, and Switzerland.
  • 제품 설명
    Philips Digital Diagnost Rel 3, a radiographic system, digital || Intended use: Radiographic system, digital
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • 제조사 주소
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA