Device Recall IMPAX 4.5, IMPAX 5.0 OT3000 Orthopedic Client, IMPAX 5.0 Orthopedic Client, IMPAX ES for Radio

  • Model / Serial
    Hectec MediCAD: ETSAN; VOXAR 3D: L72JO; and Impax 4.5 or 5.0 or 5.2 Client /OT3000: A component of Order Codes: 60+00021533, 60+00021534, 60+00022471, 60+00022472, 60+00015451, 60+00015453, 60+00021535 and 60+00024519.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including states of AR, AZ, CA, CO, DC, FL, GA, IL, IN, KY, KS, MA, MD, ME, MI, NC, NJ, NV, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA and WA, and country of Canada.
  • Product Description
    Impax 4.5, Impax 5.0, Impax 5.2 and Impax 5.2x Picture Archiving Systems (PACs) with integrated Voxar 3D software; and Impax 5.0 and Impax 5.2 PACs with integrated MediCAD software. The softwares are used to provide digital X-ray images for pre-surgical orthopedic planning. AGFA Corp., Greenville, South Carolina 29601
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    AGFA Corp., 10 S Academy St, Greenville SC 29601-2632
  • Source
    USFDA