Device Recall Dimension Vista 500 Intelligent Lab System

  • Model / Serial
    All serial numbers are affected.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product Description
    Dimension Vista 500 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
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Siemens Healthcare Diagnostics Inc., 101 Silvermine Rd, Brookfield CT 06804-2047
  • Manufacturer Parent Company (2017)
  • Source
    USFDA