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Recall Observatory FDA recall evidence

Device 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.

Z-0283-2016

September 01, 2015

Class II

Product summary

Firm
AGFA Healthcare Corp.
Event
Event 72411
Status
Terminated
Classification
Class II
Quantity
19
Official record key
device-enforcement:Z-0283-2016

Official wording

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.

Code information: Model # L9M2100

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.