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

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

Radiology Devices

2

No

Nationwide Distribution including the states of AK, GA, IL, KY, MA, NY, NC, RI, SC, TX, and VA.

IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. || Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.