Food, drugs, devices › AGFA Healthcare Corp.

Device recall: Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800

FDA enforcement event 98101 · Class II · initiated 18 Nov 2025 · status Ongoing

DeviceFDA Mandated1 product recordGreenville, SC

AGFA Healthcare Corp. (Greenville, SC) initiated this device recall on 18 Nov 2025; FDA lists 1 product record under event 98101, classified Class II.

FDA defines Class II as 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. 85% of the 945 device enforcement events initiated in 2025 carry the same class.

Status: Ongoing. Initiation: fda mandated. 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

"It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled."

Distribution

"U.S. Nationwide distribution."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0923-2026	Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800	35	Class II	Ongoing	31 Dec 2025

Context

85%of 2025 device events are Class II945 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
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
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	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: "It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is 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.

Where was the product distributed?

FDA's distribution pattern field reads: "U.S. Nationwide distribution."

Is the recall still ongoing?

FDA lists the status as Ongoing. "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.