Device Recall Horizon Medical Imaging Systems

  • Model / Serial
    Horizon Medical Imaging (HMI) versions: 4.5, 4.6.1, 5.0 without PTF-RR310-601, 11.0.3, 11.0.4, 11.0.5, 11.0.6, 11.0.6 FR EXP2 without PTF-HMI11-649, 11.0.7, 11.0.8 without PTF-HMI11-615, 11.5 and 11.5.1 without PTF-HMI115-613. On June 29, 2010 the recall was amended to include: All installations of Horizon Medical imaging (HMI) 11.0.6, 11.0.8 and 11.5.1
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed Nationwide (AK, AL, AR, AZ, CA, CO, FL, GA, IN, IA, IL, KY, LA, MA, MD, MI, NC, ND, NE, NM, NY, NV, OH, OR, PA, RI, SC, TN, TX, WY, VA and WV) and Canada
  • Product Description
    Voiceware clip software update to certain Horizon Medical Imaging Systems. McKesson Medical Imaging Company. Richmond, Canada V6X 3G5. || Intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video and associated medical information from various medical imaging systems.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Mckesson Medical Immaging, Suite 130-10711 Cambie Road, Richmond Canada British Columbia
  • Source
    USFDA