Events

Device Recall Philips Essenta DR, XRay System 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
    62650
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2207-2012
  • 사례 시작날짜
    2012-07-25
  • 사례 출판 날짜
    2012-08-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-03-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111267
  • 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
    Essenta dr c-arm may fall.
  • 조치
    Philips Medical sent an "URGENT FIELD SAFETY NOTICE" dated July 09, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers are asked to inspect the C-Arm unit and discontinue use if not parallel to the column, do not use the system and call for a Service Technician. A Field Change Order (FCO) is being released that requires an inspection of C-ARM connection and, if necessary, repair of systems. The bolts will be disconnected and thread inserts will be checked. If not the thread inserts are no longer secured, additional holes will be drilled to use in place of the original ones. For further information or support concerning this issue, contact your local Philips representative at 1-800-722-9377.

Device

Device Recall Philips Essenta DR, XRay System
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers:  SN09000006/ SN09000007/ SN10000033/ SN10000014/ SN100000654/ SN08000092/ SN08000050
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA including the states of CA, NC, and TN and the countries of China, Germany, and Hungary.
  • 제품 설명
    Philips Essenta DR, X-Ray System, Diagnostic, general-purpose || Model: 712070. || The Essenta DR is a multifunctional stationary X-ray Intended Use From Labeling): system, in which the swivel arm rotation, the vertical movement of the swivel arm and the SID adjustment are motorized. It is designed for radiographic examination of the recumbent, standing or seated patient and also for lateral exposures. It enables the operator to quickly and safely move the unit to all the pre-programmed basic positions at the press of a button, using the autopositioning feature. Fine positioning of the tube/collimator and detector on the patient is easy to carry out using the command arm.
  • 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