AGFA Corp.: Medical Device Recall in 2013 - (Recall #: Z-1070-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 15, 2013

Date Posted: April 17, 2013

Recall Number: Z-1070-2013

Event ID: 64656

Reason for Recall:

Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the hospital's electronic health record (EHR) system.

Status: Terminated

Product Quantity: 26

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated