CLASS II Device recall · Reported 5 Jul 2017 · FDA Enforcement Report

Impax Cardiovascular The Impax CV Reporting module consists recalled

Agfa Healthcare is recalling Impax Cardiovascular The Impax CV Reporting module consists of a database and graphical, distributed nationwide in the US. The recall was initiated on 22 Dec 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesVersions CV 12.2 SU3, CV 12.2 SU4, CV 12.2 SU5 and CV 12.2 SU6

Quantity recalled10

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-2652-2017
FDA event ID: 77629
Recalling firm: Agfa Healthcare, Greenville, SC
Classification: Class II
Status: Terminated
Recall initiated: 22 Dec 2016
FDA classified: 29 Jun 2017
Reported: 5 Jul 2017
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

22 Dec 2016	Recall initiated by company
29 Jun 2017	Classified by FDA	+189 days
5 Jul 2017	Published in enforcement report	+6 days

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

Reason for recall

A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm.

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 Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats

Where it was distributed

Nationwide Distribution to NJ, NC, OH, PA, SC, TN, TX, and WI

Nationwide North Carolina New Jersey Ohio Pennsylvania South Carolina Tennessee Texas Wisconsin

Questions about this recall

Why was it recalled?

A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm.

Which lots are affected?

Versions CV 12.2 SU3, CV 12.2 SU4, CV 12.2 SU5 and CV 12.2 SU6

Where was it sold?

Nationwide Distribution to NJ, NC, OH, PA, SC, TN, TX, and WI

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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