AGFA Healthcare Corp. recalls IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic…

Recall date

September 1, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0283-2016

FDA classification

Class II

Brand / firm

AGFA Healthcare Corp.

Sold / distributed

Distributed in the states of CA, KY, NH, NY, NC, OH, OR, PA, SC, SD, TN, TX, WA and the country of Canada.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.