Facility

AGFA N.V.

18 recall(s) on record — most severe on record: Class II.

Key facts

18recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3001556265
Establishment type	Manufacture Medical Device; Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility
Location	Septestraat 27 Mortsel Antwerpen, BE B-2640
Registration status	Active · expires 2026
Parent company	Agfa N.V. (owner-operator 10058267)
Brand names	NX 3; DX-D Imaging Package; DX-D 40G; DX-D 40C; DX-D 45G; DX-D 45C; DX-D 60C; DX-D 60G

Activity by year

Recalls (18)

Devices registered here (1)

Solid State X-Ray Imager (Flat Panel/Digital Imager)
Product code MQB (opens in a new tab) · Class II · Radiology · 21 CFR 892.1680

Recalls & enforcement

20242 records

Class IIOngoing2024-07-29
Potential for the front lever chain of the DR 800 table to fail.
Class IIOngoing2024-02-23
Steel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube head has potential risk -an interference could cause the safety system which blocks the arm if the cable is cut off does not work properly, may result in patient injury

20202 records

Class IITerminated2020-04-06
Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible
Class IITerminated2020-02-10
Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.

20192 records

Class IITerminated2019-06-27
The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.
Class IIITerminated2019-01-25
Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run shows pinholes in different frequencies and intensities

20181 record

Class IITerminated2018-08-15
A supplier for the Agfa system noted a potential for the steel support cables of a similar device to break. This led to a mandatory review of all systems, changing the pulley and cables if any deterioration in the cables or irregular or excessive pulley wear. If the two cables th…

20143 records

Class IITerminated2014-06-06
When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user input altering device settings.
Class IITerminated2014-04-30
Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.
Class IITerminated2014-01-08
Patient name displayed (printed) on the Patient Report was the wrong patient name.

20135 records

Class IITerminated2013-09-19
System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels.
Class IITerminated2013-05-15
Customers could potentially experience intermittent, unintended and illogical movement when using the product.
Class IITerminated2013-03-15
Software design error in IMPAX CV 7.8 SU3
Class IITerminated2013-03-15
Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the hospital's electronic health record (EHR) system.
Class IITerminated2013-02-07
The cassettes were shipped with the wrong IP (image plate) size bar code.

20123 records

Class IITerminated2012-08-09
Loss of patient data can occur under certain circumstances due to misconfiguration of DICOMstore configured with Agfa's Medical Image Storage Devices - Media Purge Daemon (MPD) and Cardiovascular Purge Service (CPS).
Class IITerminated2012-07-27
Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.
Class IITerminated2012-07-10
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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “AGFA N.V. (FEI 3001556265) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3001556265-agfa-n-v/

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