Devices

Device Recall PHILIPS EASYDIAGNOST ELEVA

  • 모델명 / 제조번호(시리얼번호)
    9890-010-88152 - Codes included in attached list. Devices were manufactured and distributed from March 2015 - March 2017.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    412 units affected.
  • 제품 설명
    Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector free in the room for X-ray exposures. It supports the wireless portable detector with or without a grid.
  • Manufacturer
    Philips Electronics North America Corporation
  • 1 Event

제조사

Philips Electronics North America Corporation
  • 제조사 주소
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 1 건

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Device Recall Philips EasyDiagnost Eleva with Digital Image (DI) Rel.2 system
  • 모델명 / 제조번호(시리얼번호)
    Site Numbers:  6931, 6934, 25834, 25901, 26140, 38086, 38195, 38196, 38279, 38500, 38539, 41111, 44282, 44656, 44657, 45070, 50230, 64158, 73286, 80306, 82503, 82630, 82646, 84939, 86395, 100727, 101142, 101555, 102034, 102169, 102590, 102591, 103421, 104104, 104810, 520185, 557985, 558101, and 558174.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: USA including states of: AZ, CA, CO, CT, DE, FL, GA, HI, ID, LA, MA, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OR, PA, SC, TN, TX, VA, WA, WI, and WY.
  • 제품 설명
    Philips EasyDiagnost Eleva with Digital Image (DI) Rel.2 system. || The Philips EasyDiagnost Eleva intended use is for the following applications: As a diagnostic-imaging device multi-functional/universal system, general R/F, Fluoroscopy, Radiography, and Angiography can be performed along with pediatric examinations and some more specialized interventional applications.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips