Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
IMPAX Recalled by AGFA Healthcare Corp. Due to Customers have experienced IMPAX CV software, specifically, Demographics...
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, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Number in previously signed reports that have since changed.
Quantity: 19
Why Was This Recalled?
Customers have experienced IMPAX CV software, specifically, Demographics Manager (DM), not producing correct pdf reports after the reports, at the time of physician signature, were correct.
Where Was This Sold?
This product was distributed to 13 states: CA, KY, NH, NY, NC, OH, OR, PA, SC, SD, TN, TX, WA
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