AGFA Corp.: FDA recalls

FDA enforcement reports name AGFA Corp. as the recalling firm in 11 events. The events have 11 product records. The recalls started from 2012 to 2014. All the events are device recalls.

See the 11 events

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.

Enforcement events

11 events, newest first.

FDA enforcement events of AGFA Corp.
Initiated	Product (first record)	Type	Class	Records	Status
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 images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest,…	Device	Class II	1	Terminated
30 Apr 2014	IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.	Device	Class II	1	Terminated
8 Jan 2014	IMPAX RIS QDOC 5.8	Device	Class II	1	Terminated
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	Terminated
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 images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest,…	Device	Class II	1	Terminated
15 Mar 2013	IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.	Device	Class II	1	Terminated
15 Mar 2013	IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management.	Device	Class II	1	Terminated
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 cassette, used to capture images from X-Ray exposures. The cassette with the image plate, once exposed, is inserted in the Agfa Digitizer CR 10-X where the image plate is taken out of the cassette…	Device	Class II	1	Terminated
9 Aug 2012	AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device	Device	Class II	1	Terminated
27 Jul 2012	IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)	Device	Class II	1	Terminated
10 Jul 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.…	Device	Class II	1	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

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

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

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Type and class

AGFA Corp.: events for each product type
Type		Events
Device		11

AGFA Corp.: events in each class
Class		Events
Class II		11

Share of the events of the firm in Class I: 0%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 0

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.

Events by year

FDA enforcement events of AGFA Corp., by the year that the recall started. The largest year is 2013, with 5 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. AGFA Corp.: FDA recalls. https://recallregister.com/firm/agfa-corp/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: SC

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of AGFA Corp. have?: Class II: 11 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of AGFA Corp.?: FDA event 68567, which the firm started on 6 Jun 2014. The first product in the record is: AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest,…
How many FDA recalls of AGFA Corp. have the status Ongoing?: No event has the status Ongoing in the openFDA file. openFDA says 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.