CLASS II Device recall · Reported 25 Nov 2015 · FDA Enforcement Report

Impax, Pacs, Picture Archive and Communications System recalled

Agfa Healthcare is recalling Impax, Pacs, Picture Archive and Communications System, Impax CV 7.8.x and Impax CV 12.x, distributed in 13 states. The recall was initiated on 1 Sep 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel # L9M2100

Quantity recalled19

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0283-2016
FDA event ID: 72411
Recalling firm: Agfa Healthcare, Greenville, SC
Classification: Class II
Status: Terminated
Recall initiated: 1 Sep 2015
FDA classified: 17 Nov 2015
Reported: 25 Nov 2015
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

1 Sep 2015	Recall initiated by company
17 Nov 2015	Classified by FDA	+77 days
25 Nov 2015	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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

California Kentucky North Carolina New Hampshire New York Ohio Oregon Pennsylvania South Carolina South Dakota Tennessee Texas Washington

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Model # L9M2100

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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