Recall Z-0283-2016— AGFA Healthcare Corp.

Name: FDA recall Z-0283-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-01

Class II · Terminated

Class II FDA medical device recall by AGFA Healthcare Corp., initiated 2015-09-01, terminated 2020-12-15. It names one FDA 510(k) clearance: K050228. 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.. 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: AGFA Healthcare Corp.
Classification: Class II
Status: Terminated
Initiated: 2015-09-01
Terminated: 2020-12-15
Firm location: Greenville, SC, United States

510(k) clearances named in this recall

1 on FDA's record

K050228 — AGFA HEARTLAB CARDIOVASCULARHeartlab, Inc.·cleared 2005-02-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.