Hitachi Echelon Oval MRI system

Manufacturer

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    Product Codes: Y001, Y002, Y003, Y004, Y005, Y006, Y007, Y008, Y009, Y010, Y011, Y012, Y014, Y015, Y016, Y101, Y102, Y103, Y105, and Y951. To be updated as firm submits information.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, ID, KS, KY, MD, MS, NY, OH, and WY; countries of: Japan, Brazil, France, Germany, and Kyrgyzstan.
  • Product Description
    Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation.
  • Manufacturer
  • Model / Serial
    Y001, Y002, Y003, Y004, Y005, Y006, Y007, Y008, Y009, Y010, Y011, Y012, Y013, Y014, Y015, Y016, Y101, Y102, Y103, Y104, Y105, Y106, Y107, Y108, Y951
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US nationwide distribution. The products were distributed to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. There are four (4) government accounts for this recall: VA Medical Center/Lyster Army Health Clinic, Building 301 - Andrews Avenue, Fort Rucker, AL 36362; Parma VA Medical Center, 8787 Brookpark Rd, Parma, OH 44129; Viera VA Outpatient Clinic, 2900 Veterans Way, Viera, FL 32940; Perry Point VA Medical Center, Avenue D, Suite 1A-120, Perry Point, MD 21902. There are zero (0) Canada accounts for this recall. There are two (2) Mexico accounts for this recall: Hospital General Tipo "B" de Alta Especialidad - SMH, "Fraccionamiento 1 De La Parcela 101, Del Ejido De Atapaneo", Morelia, MX 58300; Hospital General de Occidente, Zoquipan 1050 Avenue, Zapopan Jalisco, MX 45170 The product was distributed to the following countries: Brazil.
  • Product Description
    Hitachi Echelon Oval MRI System
  • Manufacturer