BEUDAMED
    FDA Recall Terminated

    Hitachi Echelon Oval MRI System

    Recall: Z-1541-2017 · Initiated April 16, 2015

    Recall

    Recall Number
    Z-1541-2017
    Event Number
    76373
    Firm
    Hitachi Medical Systems America Inc
    FEI Number
    1528028
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Software in the Use Environment
    Initiated
    April 16, 2015
    Posted
    March 23, 2017
    Terminated
    June 29, 2017
    Address
    1959 Summit Commerce Park, Twinsburg, OH, 44087-2371

    Description

    Hitachi Echelon Oval MRI System

    Reason

    Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.

    Action

    Formal notification letters were sent to consignees on 2/13/17. Hitachi Service will update the software at each site during visits.

    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.

    Quantity

    25 units