BEUDAMED
    FDA Recall Terminated

    Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System, analyzer, chemistry (photometric, discrete), for clinical use Product Usage: The Siemens Healthcare Diagnostics 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-1703-2017 · Initiated March 3, 2017

    Recall

    Recall Number
    Z-1703-2017
    Event Number
    76690
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 3, 2017
    Posted
    March 19, 2017
    Terminated
    July 3, 2018
    Address
    500 Gbc Dr PO BOX 6101, Ms 514, Newark, DE, 19702-2466

    Description

    Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System, analyzer, chemistry (photometric, discrete), for clinical use Product Usage: The Siemens Healthcare Diagnostics 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

    Siemens Healthcare Diagnostics has confirmed that in isolated cases when ECREA is processed immediately after the weekly automated Acid Clean routine during Probe Test, there is the remote potential for an elevation of greater than 15 percent in the ECREA result.

    Action

    Siemens mailed an Urgent Medical Device Correction Notice letter dated March 3, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact Siemens Customer Care Center - Technical Solutions at (800-441-9250) or your local Siemens Technical Support Representative.

    Distribution

    Worldwide Distribution - United States Nationwide and Puerto Rico, Canada, Qatar, Republic Korea, Saudi Arabia, Slovakia, Slovenia, Spain, Switzerland, United Kingdom, Australia, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, and Portugal.

    Quantity

    2733 systems