Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
IMPAX CV Pediatric Echo Reporting Recalled by AGFA Corp. Due to Failure to effectively install and test a hotfix...
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 Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.
Quantity: One
Why Was This Recalled?
Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.
Where Was This Sold?
This product was distributed to 1 state: SC
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