Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Recalled by AGFA Corp. Due to Baseline pulmonary capillary wedge (PCW) pressure values from...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact AGFA Corp. directly.
Affected Products
IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.
Quantity: 26
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About AGFA Corp.
AGFA Corp. has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report