Events

Device Recall Philips Heatlhcare 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems, 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
    70432
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1251-2015
  • 사례 시작날짜
    2015-01-23
  • 사례 출판 날짜
    2015-03-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-06-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133671
  • 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, x-ray, stationary - Product Code KPR
  • 원인
    Improper installation of tube arm, and wall stand may cause it to fall down, improper installation of table may cause it to float.
  • 조치
    Philips Healthcare issued notice to foreign Distributors on 1/23/15 to issue and advise customers to stop using the device until a Philips Engineer checks the device. After the engineer verifies that the tube arm, Wall stand and table were properly assembled, the device may be used again. Philips will subsequently install a new Tube Arm and Wall stand fixing structure that is designed to prevent this hazard if the tube arm or Wall stand is incorrectly reinstalled in the future. Philips will subsequently provide the method to adjust the T-nuts of table to make sure it was properly assembled. A Philips Service Engineer will contact affected customers to install the solution.

Device

Device Recall Philips Heatlhcare
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: SN120001 SN120002 SN120003 SN130001 SN130002 SN130004 SN130005 SN130015 SN130019 SN130021 SN130003 SN130006 SN130007 SN130009 SN130010 SN130011 SN130012 SN130013 SN130014 SN130016 SN130017 SN130018 SN130020 SN130022 SN130023 SN140001 SN130001 SN130002 SN140001 SN140004 SN140005 SN140008 SN140009 SN140010 SN140012 SN140013 SN140019 SN140020 SN140021 SN140022 SN140024 SN140027 SN140033 SN140034 SN140036 SN140053 SN140062 SN130003 SN140002 SN140003 SN140006 SN140007 SN140016 SN140017 SN140018 SN140031 SN140035 SN140037 SN140039 SN140040 SN140041 SN140044 SN140045 SN140046 SN140048 SN140050 SN140051 SN140052 SN140056 SN140058 SN140060
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution. Argentina, Australia, Burkina-Faso, Chile, China, Colombia, Ecuador, France, Germany, Hungary, Indonesia, Iraq (NL), Kuwait, Libya, Macedonia, Malaysia, Mayotte, Poland, Saudi Arabia, Slovenia, Spain, Switzerland, Turkey, United Kingdom, and Uzbekistan.
  • 제품 설명
    Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic || Models: 712210, 712211
  • Manufacturer
    Philips Medical Systems, Inc.

Manufacturer

Philips Medical Systems, Inc.
  • 제조사 주소
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA