AGFA Healthcare Corp.

FDA recalling firm · 12 enforcement events · 12 product records · 2014–2025 · SC

AGFA Healthcare Corp. has 12 FDA enforcement events on this register (12 product records) between 2014 and 2025: 12 device; the busiest year was 2014 with 4.

0% of its events are Class I; the most common class is Class II (9). 1 event is listed as ongoing; the recalling firm's address is in SC.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
18 Nov 2025	Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800	Device	Class II	1	Ongoing
22 Dec 2016	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	Device	Class II	1	Terminated
21 Dec 2016	Agfa Healthcare NX 3.0.8950 Imaging Processing Software	Device	Class II	1	Terminated
2 May 2016	DX-D600 - DXD Imaging Package	Device	Class II	1	Terminated
20 Jan 2016	AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis	Device	Class II	1	Terminated
1 Sep 2015	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.	Device	Class II	1	Terminated
26 Jun 2015	IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for…	Device	Class II	1	Terminated
29 May 2015	AGFA DX-D 100 is a mobile digital radiography x-ray system	Device	Class II	1	Terminated
24 Oct 2014	Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat M+ NIF 25,4CM x 30,5CM	Device	Class III	1	Terminated
16 Jul 2014	Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists of a thin sheet of radiotransparent…	Device	Class III	1	Terminated
2 Jul 2014	DX-D 600 - DXD Imaging Package Product Usage: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, check abdomen and other both…	Device	Class II	1	Terminated
13 May 2014	Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.	Device	Class III	1	Terminated

By type and class

Device12

Class II9

Class III3

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for AGFA Healthcare Corp. by year initiated.

Questions and answers

How many FDA recalls has AGFA Healthcare Corp. had?

12 enforcement events (12 product records) on this register, 2014–2025: 12 device.

Are any AGFA Healthcare Corp. recalls ongoing?

1 event is listed as ongoing in the current openFDA export.

What class are AGFA Healthcare Corp. recalls?

9 Class II, 3 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.