Devices

Device Recall IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting

  • Model / Serial
    Model # L9M21000. Software versions: IMPAX CV 7.8, 7.8 SU1, 7.8 SU2 and 7.8 SU3, IMPAX CV 7.8 SU2.5 with IMPAX CV Outbound Report Stylesheet 7.8_HL
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of AK, GA, IL, KY, MA, NY, NC, RI, SC, TX, and VA.
  • Product Description
    IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. || Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.
  • Manufacturer
    AGFA Corp.
  • 1 Event

Manufacturer

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