AGFA Healthcare Corp.: Medical Device Recall in 2015 - (Recall #: Z-0283-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 1, 2015

Date Posted: November 25, 2015

Recall Number: Z-0283-2016

Event ID: 72411

Reason for Recall:

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.

Status: Terminated

Product Quantity: 19

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.

Voluntary or Mandated:

Voluntary: Firm initiated