Company: AGFA Healthcare Corp.
Date of Enforcement Report 11/25/2015
Class lI:
PRODUCT
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.
Recall Number Z-0283-2016
REASON
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.
RECALLING FIRM/MANUFACTURER
AGFA Healthcare Corp, Greenville, SC on 9/1/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
19
DISTRIBUTION
Distributed in the states of CA, KY, NH, NY, NC, OH, OR, PA, SC, SD, TN, TX, WA and the country of Canada.
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