Device Recall Hitachi Oasis MRI System CSpine Coil

  • Model / Serial
    M001 to M028, M029 to M083, M085 to M090, M092 to M104, M106, M110 to M111, M113 to M114, M116 to M123, M125, M128 to M131, M133, M139 to M141, M143 to M147, M150, M152, M154, M159, M161, M163, M166, M169 to M176, M179, M182, M183, M185, M186, M190, M194 to 196, M201, M207 to M238
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA (nationwide) distribution. The product was 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, NC, ND, NH, NJ, NM, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. There are three (3) government accounts for this recall: VA Medical Center/Lyster Army Health Clinic, Parma VA Medical Center, Outpatient Clinic. There are no Canada accounts for this recall. There are no Mexico accounts for this recall.
  • Product Description
    Hitachi Oasis MRI System - C-Spine Coil
  • Manufacturer
  • 1 Event

Manufacturer

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