Device Recall Vital Connect

  • Model / Serial
    Any VitalConnect version, or the Vitrea Core component of Vitrea Enterprise Suite (VES) 1.2 adn VES 1.3.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA including states of: AK, AZ, CA, CO, CT, FL, GA, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MO, NH, NJ, NM, NY, NC, ND, OH, PA, SC, TN, TX VA, WV, WI, and WY; and countries of: AUSTRALIA, HONG KONG, UNITED KINGDOM, NETHERLANDS, FRANCE, BELGIUM, CANADA, CHINA, AUSTRALIA, SWITZERLAND, and ITALY.AUSTRALIA, HONG KONG, UNITED KINGDOM, NETHERLANDS, FRANCE, BELGIUM, CANADA, CHINA, AUSTRALIA, SWITZERLAND, ITALY.
  • Product Description
    Vital Connect 4.0 & 4.1, radiological image processing software || A Medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT MR, CR/DR/DX, SC, US, NM, PET, XA and RF, etc. Vital connect has the following intended use: Vessel Probe is intended for viewing the anatomy and pathology of a patient's coronary arteries. Clinicians select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotate-able curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Vital Images, Inc., 5850 Opus Parkway Suite 300, Plymouth MN 55343-4414
  • Manufacturer Parent Company (2017)
  • Source
    USFDA