Food, drugs, devices › AGFA Healthcare Corp.

Device recall: 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

FDA enforcement event 68844 · Class III · initiated 16 Jul 2014 · status Terminated · terminated 9 Dec 2014

DeviceVoluntary: Firm initiated1 product recordGreenville, SC

FDA enforcement event 68844 is a device recall by AGFA Healthcare Corp. of Greenville, SC, initiated 16 Jul 2014 and classified Class III, with 1 product record.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,176 device enforcement events initiated in 2014 carry the same class.

Status: Terminated, terminated 9 Dec 2014. Initiation: voluntary: firm initiated. AGFA Healthcare Corp. has 12 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

AGFA Healthcare Corp., Greenville, SC.

Reason for recall

"Some sheets of the medical screen film are fogged."

Distribution

"Worldwide Distribution and US Nationwide in the states of AL, AZ, CA, FL, IL, LA, MI, MN, MS, NE, NH, NJ, NC and country of Canada"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-2178-2014	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…	2617	Class III	Terminated	20 Aug 2014

Context

4%of 2014 device events are Class III1,176 events that year

1product record in this eventfirm median: 1

12events on this register for the firm

Other enforcement events for AGFA Healthcare Corp.

Initiated	Product (first record)	Type	Class	Records
18 Nov 2025	Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800	Device	Class II	1
22 Dec 2016	IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows	Device	Class II	1
21 Dec 2016	Agfa Healthcare NX 3.0.8950 Imaging Processing Software	Device	Class II	1
2 May 2016	DX-D600 - DXD Imaging Package	Device	Class II	1
20 Jan 2016	AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid	Device	Class II	1
1 Sep 2015	IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic i	Device	Class II	1
26 Jun 2015	IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provides	Device	Class II	1
29 May 2015	AGFA DX-D 100 is a mobile digital radiography x-ray system	Device	Class II	1
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
2 Jul 2014	DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to aid the phys	Device	Class II	1

All 12 events for AGFA Healthcare Corp.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Some sheets of the medical screen film are fogged."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide Distribution and US Nationwide in the states of AL, AZ, CA, FL, IL, LA, MI, MN, MS, NE, NH, NJ, NC and country of Canada"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 9 Dec 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.