Devices

Device Recall Hitachi SCENARIA CT System

  • Model / Serial
    Serial #'s: S5002-S5014; S5017-S5038
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : CA, FL, GA, IA, IL, IN, MD, NC, NY, OH, PA, SD, TN, TX & WY., and Internationally to Brazil and Mexico.
  • Product Description
    Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
  • Manufacturer
    Hitachi Medical Systems America Inc
  • 1 Event

Manufacturer

Hitachi Medical Systems America Inc
  • Manufacturer Address
    Hitachi Medical Systems America Inc, 1959 Summit Commerce Park, Twinsburg OH 44087-2371
  • Manufacturer Parent Company (2017)
    Hitachi Ltd
  • Source
    USFDA

One device with a similar name

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Device Recall Hitachi Scenaria CT System Software
  • Model / Serial
    Serial #'s S5001 - S5011
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution to the following states of: MD, MI, MX, ND, NY, OH and TX.
  • Product Description
    Hitachi Scenaria CT System Software || Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the Scenaria can be post processed by the Scenaria to provide additional information. Post processing capabilities included in the Scenaria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.
  • Manufacturer
    Hitachi Medical Systems America Inc