BEUDAMED
    FDA Recall Terminated

    Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensor technology for clinical use

    Recall: Z-1886-2016 · Initiated March 24, 2016

    Recall

    Recall Number
    Z-1886-2016
    Event Number
    73885
    Firm
    Siemens Healthcare Diagnostics Inc.
    FEI Number
    3002755490
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 24, 2016
    Posted
    June 1, 2016
    Terminated
    March 13, 2017
    Address
    101 Silvermine Rd, Brookfield, CT, 06804-2047

    Description

    Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensor technology for clinical use

    Reason

    Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confirmed a software defect which, in a very specific set of circumstances, results in the Dimension Vista System omitting an aliquot probe rinse between sample aspirations when processing tubes in Sample Racks that are front loaded on the Dimension Vista System.

    Action

    Siemens sent an Urgent Medical Device Correction letter dated March 24, 2016, to all affected customers. Customers were advised to follow the instructions contained in the "Urgent Medical Device Correction" notification letter to help minimize or eliminate the impact that this specific software defect could cause until a software correction could be made (i.e instructions to minimize the impact of the software defect due to "Bad Sample Detect " False Transition" errors when processing front loaded samples) and (how to eliminate the impact of the software defect when processing front loaded samples). Customers were also asked to review the recall notification letter with their Medical Director and complete and return the Field Correction Effectiveness Check Form within 30 days. Customers with questions were advised to contact Siemens Customer Care Center - Technical Solutions at 800-441-9250 or their local Siemens technical support representative. For questions regarding this recall call 302-631-8248.

    Distribution

    Nationwide Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, , ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico.

    Quantity

    1300