FDASeptember 1, 2015device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
agfa healthcareagfa
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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