Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
IMPAX Cardiovascular The IMPAX CV Reporting module consists of a Recalled by AGFA Healthcare Corp. Due to A customer experienced when using IMPAX CV Reporting...
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 Healthcare Corp. directly.
Affected Products
IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats
Quantity: 10
Why Was This Recalled?
A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About AGFA Healthcare Corp.
AGFA Healthcare Corp. has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report