Device recall: IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating…

Class II FDA enforcement event 62534. Recall start date: 10 Jul 2012. Status in the FDA record: Terminated. Termination date: 29 Oct 2013.

Reason for recall, in the words of FDA

When users selected "Left stenosis" in the "Graft Duplex Conclusion" section in IMPAX CV Reporting Non-Invasive(NIV) module, "Right stenosis" appeared in the sentence display within the printed representation of the report.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

AGFA Corp. started this device recall on 10 Jul 2012. The firm address in the FDA record is in Greenville, SC. FDA put the recall in Class II. FDA event 62534 has 1 product record. The first FDA enforcement report date is 1 Aug 2012. The record gives the status Terminated, with the termination date 29 Oct 2013.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide Distribution including IN, SC, OH, TX

Recalling firm

AGFA Corp., Greenville, SC.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 62534: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2069-2012	IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, pediatric echocardiography, congenital heat disease, nuclear cardiology and non-invasive vascular disease management.…	6	Class II	Terminated	1 Aug 2012

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2012: 823
Share of these events in Class II: 88%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 11

Other events of the firm

Other FDA enforcement events of AGFA Corp.
Initiated	Product (first record)	Type	Class	Records
6 Jun 2014	AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality imag	Device	Class II	1
30 Apr 2014	IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPA	Device	Class II	1
8 Jan 2014	IMPAX RIS QDOC 5.8	Device	Class II	1
19 Sep 2013	IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).	Device	Class II	1
15 May 2013	AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality imag	Device	Class II	1
15 Mar 2013	IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for cathe	Device	Class II	1
15 Mar 2013	IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital s	Device	Class II	1
7 Feb 2013	CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in an X-Ray c	Device	Class II	1
9 Aug 2012	AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS),	Device	Class II	1
27 Jul 2012	IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (includin	Device	Class II	1

AGFA Corp.: all 11 events

Official channels

FDA enforcement report Z-2069-2012The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 62534. https://recallregister.com/fda/ii/62534/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide Distribution including IN, SC, OH, TX
What quantity of product is in FDA event 62534?: The FDA record gives this quantity: 6
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2012 have the same class?: 88% of the 823 device events that started in 2012 are in Class II.