Z-0283-2016Class II

IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain...

Name: Z-0283-2016 IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain...
Creator: AGFA Healthcare Corp.
Published: 2015-09-01
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2015-09-01 / Terminated / root cause: software

FDA source

AGFA Healthcare Corp. began a recall of IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient... on 2015-09-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0283-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-01
Posted: 2015-11-17
Terminated: 2020-12-15
Recalling firm: AGFA Healthcare Corp.
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.
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA root cause: Software design
Action: An Urgent Field Safety Notice was sent to accounts via email on 9/1/2015. The letter described the safety alert. Customers were informed of the problem and that Service would be contacting them to arrange a date to deploy the corrective action and install the Service Update at their facility. An acknowledgement was included which was to be faxed back or emailed back to Agfa.
Quantity 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.
Product codes and lots: Model # L9M2100

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0283-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0283-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-17

Product code LLZ

K050228Class IIAgfa Heartlab CardiovascularHeartlab, Inc. / cleared 2005-02-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)