Devices

Device Recall NeuViz Dual series computed Tomography Scanner System

  • Modèle / numéro de série
    Serial numbers 400562, 400563, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, and NDH034EI
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The units were distributed to one distributor in NC, and further distributed to medical facilities located in CO, FL, KY, NC, SC, TN and TX.
  • Description du dispositif
    NeuViz Dual series computed Tomography Scanner System, X-Ray System
  • Manufacturer
    Philips And Neusoft Medical Systems Co., Ltd.
  • 1 Event

Fabricant

Philips And Neusoft Medical Systems Co., Ltd.
  • Adresse du fabricant
    Philips And Neusoft Medical Systems Co., Ltd., 16 Century Road, Neusoft Park,, Hun Nan Industrial Area, Shenyang, Liaoning China
  • Source
    USFDA

Un dispositif médical avec un nom similaire

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Device Recall NeuViz Dual Series Computed Tomography Scanner System
  • Modèle / numéro de série
    Part number: NeuViz Dual 989605651321.  SERIAL NUMBERS:  400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002, NDHR080003, NDHR080004, NDHR080007, NDHR080012, NDHR080021, NDHR080031, NDHR090003, and NDHR090012.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including NC
  • Description du dispositif
    The device is the NeuViz Dual series Computed Tomography (CT) Scanner System. The device is identified as NeuViz Dual, PN: 989605651321. || Labeling on the device reads in part: "***Neusoft NeuViz Dual MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD. ADDRESS: NEUSOFT PARK, HUN NAN INDUSTRIAL AREA, SHENYANG 110179, CHINA***". || Device is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles.
  • Manufacturer
    Philips And Neusoft Medical Systems Co., Ltd.