Device Recall TSX301A: AQUILION ONE

  • Model / Serial
    Last 4 of serial number: 2005, 2008, 2010, 2023, 2026, 2034, 2036, 2038, 2048, 2049, 2051, 2052, 2053, 2061, 2063, 2067, 2070, 2071, 2072, 2077, 2080, 2092, 2115, 2116, 2006, 2007, 2008, 2123, 2131, 2133, 2011, 2139, 2143, 2148, 2151, 2014, 2161, 2162, 2165, 2167, 2168, 2169, 2170, 2002, 2004, 2158, 2166, 2174
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: AL, AR, AZ, CA, CO, FL, GA, IA, KY, LA, MA, MD, MI, MN, MT, ND, NJ, NV, NY, OH, PA, PR, TX, VA, WI, and WY.
  • Product Description
    TSX-301A: AQUILION ONE System || AQUILION ONE is a multislice CT system that supports whole body scanning. The system supports simultaneous data acquisitions of 320 slices using the Selectable Slice-thickness Multi-row Detector.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Toshiba American Medical Systems Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92781-2068
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

  • Model / Serial
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    TSX-301A: AQUILION One; System, X-Ray, Tomography, Computed || X-Ray Tomography
  • Manufacturer
  • Model / Serial
    Lot number is not utilized
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution - USA (nationwide) and Puerto Rico
  • Product Description
    TSX-301A: AQUILION ONE; System, X-Ray, Tomography, Computed || Last four of Serial Number: || 2005, 2008, 2010, 2023, 2026, 2034, 2036, 2038, 2048, 2049, 2051, 2052, 2053, 2061, 2063, 2067, 2070, 2071, 2072, 2077, 2080, 2092, 2115, 2116, 2123, 2131, 2133, 2139, 2143, 2148, 2151, 2158, 2161, 2162, 2165, 2167, 2168, 2169, 2170, 2174, 2208, 2211, 2212, 2219, 2220, 2222, 2241, 2253, 2257, 2265, 2275, 2283, 2284, 2291, 2294, 2308, 2311, 2316, 2324, 2328, 2332, 2333, 2006, 2007, 2008, 2011, 2014, 2015, 2016, 2017, 2018, 2019, 2020, 2021, 2022, 2025, 2027, 2030, 2031, 2032, 2033, 2035, 2002, 2004. || Aquilion One is a multislice CT system that supports whole body scanning. The system supports simultaneous data aquisition of 320 slices using the Selectable Slice-thickness Multi-row Detector (SSMD). In addition, the high speed rotation mechanism and the reconstruction unit of the system allow quick image acquisition to further improve throughput in CT examinations. Aquilion ONE, Toshiba's top of the line X-ray CT system, is provided with a 7.5 MHU large capacity X-ray tube unit and detector and permits scanning at the high speed per rotation.
  • Manufacturer