Device Recall Philips Essenta DR, XRay System

  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers:  SN09000006/ SN09000007/ SN10000033/ SN10000014/ SN100000654/ SN08000092/ SN08000050
  • 의료기기 분류등급
  • 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
  • 1 Event

제조사

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