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Agfa NV

Belgium·BE-MF-000000571

Last updated September 18, 2026

About

Agfa Radiology Solutions delivers diagnostic imaging solutions that set standards in productivity, safety, clinical value and cost effectiveness.

From the manufacturer's own website. Source

Information

Country: Belgium
Address: 27, Septestraat, Mortsel, Belgium
Website: medimg.agfa.com/main/
LinkedIn: linkedin.com/company/18447368
Facebook: facebook.com/agfaradiologysolutions
Email: [email protected]
Phone: —
PRRC Contact: Koen Vervoort
EUDAMED SRN: BE-MF-000000571
FDA FEI Number: —
DUNS Number: —

Catalogue (86)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
E.O.S. Fix	EF2AL	EUDAMED	Class I	Active
Drystar Dt 5 B	51BOB	EUDAMED	Class I	Active
Cr 15-X	5YEBG	EUDAMEDFDA UDI	Class IIa	Active
Crystal Film Cf-B	5YH1A	EUDAMEDFDA UDI	Class I	Active
Cr Mm3.0 Mammo Set	10+9999912140 / ESWE4	EUDAMED	Class IIa	Active
Drystar 5301	57KAX	EUDAMED	Class I	Active
WS-Motorized-T-001	5423W	EUDAMED	Class I	Active
G150	EFBAK	EUDAMED	Class I	Active
Drystar Dt 2 Mammo	5VCEO	EUDAMED	Class I	Active
G153	HT536	EUDAMED	Class I	Active
Drystar Dt 2 Mammo	ERE6E	EUDAMEDFDA UDI	Class I	Active
G334i	392UO	EUDAMED	Class I	Active
Crystal Film Cf-B	5YHZ7	EUDAMEDFDA UDI	Class I	Active
Crystal Film Cf-M	5YH6L	EUDAMEDFDA UDI	Class I	Active
Cr Md1.0 Cassette Adapter	5ZGHB	EUDAMED	Class I	Active
Crystal-M Imager	5YGOF	EUDAMEDFDA UDI	Class I	Active
DX FLFS Horizontal Overlay	5XRYZ	EUDAMED	Class I	Active
Crystal Film Cf-B	5YH2C	EUDAMEDFDA UDI	Class I	Active
Drystar Dt 2 B	EKL4B	EUDAMED	Class I	Active
DR 600 FLFS Horizontal Overlay	53B1J	EUDAMED	Class I	Active
DR FLFS Detector Positioner	XFG9V	EUDAMED	Class I	Active
Dr 600	MARDQ	EUDAMEDFDA UDI	Class IIb	Active
Drystar AXYS	EYZ4E	EUDAMEDFDA UDI	Class I	Active
Drystar Dt 5 B	51BPD	EUDAMED	Class I	Active
Nx 4.0	XCU8O	EUDAMEDFDA UDI	Class IIb	Active
DX-D FLFS Stand	5SN1F	EUDAMED	Class I	Active
Easylift	MAAQJ	EUDAMED	Class I	Active
Full Body Cassette Holder	EAUGV	EUDAMED	Class I	Active
Crystal Film Cf-B	5YH3E	EUDAMEDFDA UDI	Class I	Active
Cr Md1.0 General Set	5YEGR	EUDAMEDFDA UDI	Class IIa	Active
Dr 400	MBFTK	EUDAMEDFDA UDI	Class IIb	Active
G139	3ZBEK	EUDAMED	Class I	Active
Cawo Dry Film	54R5T	EUDAMED	Class I	Active
Dr 400	51FS1	EUDAMEDFDA UDI	Class IIb	Active
G334	EKNCY	EUDAMED	Class I	Active
Cawo Dry Mammo Film	59CM8	EUDAMED	Class I	Active
Cr Phosphor Plate Cleaner	MARCO	EUDAMED	Class I	Active
Dr 800	XCTMA	EUDAMEDFDA UDI	Class IIb	Active
G150	EFBDQ	EUDAMED	Class I	Active
Drystar Dt 5 B	51BN8	EUDAMED	Class I	Active
WS-Manual-002	58UDL	EUDAMED	Class I	Active
Crystal Film Cf-M	5YH4G	EUDAMEDFDA UDI	Class I	Active
Nx 3.0	E3M81	EUDAMEDFDA UDI	Class IIb	Active
Drystar Dt 2 B	EKL38	EUDAMED	Class I	Active
Crystal Imager	5YGND	EUDAMEDFDA UDI	Class I	Active
G354	EFBCO	EUDAMED	Class I	Active
Cr Md1.0 General Set	5R3GU	EUDAMEDFDA UDI	Class IIa	Active
Drystar Dt 5 Mammo	51BQF	EUDAMED	Class I	Active
Cr Md4.0 General Set Sr	10+9999911960 / EJY2J	EUDAMED	Class IIa	Active
G354	EFBBM	EUDAMED	Class I	Active

Related Companies

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FDA Recalls (57)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jun 6, 2014	Z-2081-2014	—	terminated	When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user input altering device settings.
Apr 30, 2014	Z-1662-2014	—	terminated	Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.
Jan 8, 2014	Z-0919-2014	—	terminated	Patient name displayed (printed) on the Patient Report was the wrong patient name.
Sep 19, 2013	Z-0035-2014	—	terminated	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.
May 15, 2013	Z-1487-2013	—	terminated	Customers could potentially experience intermittent, unintended and illogical movement when using the product.
Mar 15, 2013	Z-1070-2013	—	terminated	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.
Mar 15, 2013	Z-1069-2013	—	terminated	Software design error in IMPAX CV 7.8 SU3
Feb 7, 2013	Z-0970-2013	—	terminated	The cassettes were shipped with the wrong IP (image plate) size bar code.
Aug 9, 2012	Z-2252-2012	—	terminated	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).
Jul 27, 2012	Z-2184-2012	—	terminated	Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.
Jul 10, 2012	Z-2069-2012	—	terminated	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.
Jan 16, 2012	Z-1062-2012	—	terminated	The firm received a complaint that when using the DX-D Mobile DR X-Ray unit they noticed the detector cable was hot.
Dec 6, 2011	Z-0591-2012	—	terminated	Occasionally images can be lost or sent to an incorrect folder or the digitizer may stop either during startup or during a cassette scan cycle.
Oct 4, 2011	Z-0285-2012	—	terminated	The film notch was located in the wrong position.
Jun 6, 2011	Z-0211-2012	—	terminated	Improper merging of IMPAX Cardiovascular Results Management (RM) reports causes the signed report to become unavailable.
Jun 6, 2011	Z-0212-2012	—	terminated	Incorrect entries in mapping files could lead to inaccurate measurement display in adult and pediatric echo reports when using the IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR).
Jun 6, 2011	Z-0272-2012	—	terminated	Potential for misattribution of data and for a report to become unavailable when the user requests for it to be moved to another study that already has a report associated with it.
Apr 5, 2011	Z-2246-2011	—	terminated	Software issue that occurs after dictation of a study.
Mar 21, 2011	Z-2552-2011	—	terminated	Customer error with the angiography (XA: X-Ray Angiography) measurement calibration functionality within the Cardiovascular Review Station resulted in improper calibration.
Mar 4, 2011	Z-2137-2011	—	terminated	When a radiographer is working on two open studies on an NX workstation and, in specific situations, a problem of image/annotation mix-up can occur on the NX system.
Feb 10, 2011	Z-1676-2011	—	terminated	A discrepancy in the validation testing which resulted in the product not performing as intended.
Jan 27, 2011	Z-1434-2011	—	terminated	Echocardiography volume measurements performed within CRS were not reflected correctly in associated Results Management (RM) reports.
Oct 22, 2010	Z-0835-2011	—	terminated	Product did not receive UL Certification
Oct 8, 2010	Z-0464-2011	—	terminated	Packaging was switched between a DX-G Digitizer and a DX-M Digitizer, resulting in the wrong product, which is not sold in the US, being shipped to the consignee.
Jun 30, 2010	Z-2100-2010	—	terminated	Monitor fell from the mounting bracket used to support the monitor.
Jun 11, 2010	Z-2112-2010	—	terminated	Agfa Service technician had incorrectly modified a report template at one site resulting in erroneous anatomic segment locators.
Apr 22, 2010	Z-1799-2010	—	terminated	The RF tags on the white protection sheets of the media stacks were incorrect.
Mar 2, 2010	Z-0916-2012	—	terminated	Labeling problem
Jul 16, 2009	Z-1887-2009	—	terminated	Measurements are inaccurate on multiple workstations.
Jun 22, 2009	Z-1889-2009	—	terminated	After opening and closing a study on a Central Monitoring System while a study is still open on an in-room NX system, a problem of image mix-up can occur on the in-room NX system.
May 7, 2009	Z-0366-2010	—	terminated	HeartStation does not refresh content changes to the PDF reports that are printed emailed or faxed from the Index page. This may lead to a discrepancy in patient demographics between what is displayed in the HeartStation Client interface and the report delivered to the consumer. Questions are being directed to the local Agfa representative; the contact information was included in the letter.
Apr 15, 2009	Z-1435-2011	—	terminated	User could modify a measurement's units and that change would not be reflected in echocardiography formulas used within the Adult echocardiography RM.
Dec 24, 2008	Z-0945-2009	—	terminated	Polling procedure may fail when multiple merge/split is carried out.
Jun 4, 2008	Z-2180-2008	—	terminated	The IMPAX client failed to "refresh" the image area upon receiving a study retrieved from archive. The system also erroneously displays this study retrieved from archive as the "active" study.
May 16, 2008	Z-2136-2008	—	terminated	The "Film Calibration" setting on the printers was set to the default "OFF" position instead of "ON".
Feb 22, 2008	Z-1349-2008	—	terminated	Reporting Differences: The Outbound Report software produces an Outbound Report (text version) which does not contain all the clinical content elements present in the PDF version of the report, also generated on the Nuclear Cardiology Reporting Module.
Dec 11, 2007	Z-1306-2008	—	terminated	Failure of Data Transmission: No imaging data could be transmitted by the device, because a key value needed for data transmission was incorrectly entered in the affected units by AGFA Healthcare.
Jul 27, 2007	Z-1242-2008	—	terminated	Incorrect Results: Erroneous echocardiographic measurement values due to mathematical formula being mis-configured.
Jun 28, 2007	Z-1245-2008	—	terminated	Text and Images may not be synchronized.
Jun 21, 2007	Z-1241-2008	—	terminated	MIsidentification: The electrocardiogram (ECG) data of one patient is misidentified as the data of another patient.
May 14, 2007	Z-1244-2008	—	terminated	Java version 1.6x (JAVA 6) is not compatible with AGFA IMPAX Administration/Service Tools. Due to a Software Mismatch data can be lost.
May 14, 2007	Z-1243-2008	—	terminated	Java version 1.6x (JAVA 6) is not compatible with AGFA IMPAX Administration/Service Tools. Due to a Software Mismatch data can be lost.
Feb 15, 2007	Z-1307-2008	—	terminated	Misidentification: The orthopedic planning X-ray images for one patient are misidentified as the images for another patient.
Sep 1, 2006	Z-0219-2007	—	terminated	Users may experience one or more of four (4) problems; 1. Image quality problem with full leg full spine exams. 2. Unable to print 2 or more images on 1 film. 3. Possible image loss when printing. 4. Study date and time not showing up on Imexius Web.
Aug 8, 2006	Z-0033-2007	—	terminated	Failed CAD displayed as 'No Findings'
Jun 30, 2006	Z-1256-06	—	terminated	Possible corrupted image appearing after System Start.
Jun 28, 2006	Z-0031-2007	—	terminated	Three separate issues involving the Agfa DX-S CR System, were detected that could lead to an image loss.
Feb 16, 2006	Z-0756-06	—	terminated	A localized fog pattern appears on the film.
Feb 16, 2006	Z-0755-06	—	terminated	A localized fog pattern appears on the film.
Feb 16, 2006	Z-0788-06	—	terminated	The film was incorrectly notched.
Feb 16, 2006	Z-0754-06	—	terminated	A localized fog pattern appears on the film.
Dec 21, 2005	Z-0471-06	—	terminated	Mislabeling; Product labeled Cronex 10T actually contains Afga, Curix Ultra UVL Plus.
Nov 18, 2005	Z-0353-06	—	terminated	Users of affected systems may experience one or more of four (4) problems the clinical impact could be a loss of image(s), the need to repeat the imaging procedure and, possibly, a short delay in diagnosis.
Nov 18, 2005	Z-0352-06	—	terminated	Users of affected systems may experience a loss of images, the need to repeat the imaging procedure and possibly a short delay in diagnosis.
Nov 3, 2005	Z-0855-06	—	terminated	Corrupted image after system start; Corrupted image after workflow interruption; An erasure unit problem can cause system to stop.
Jan 26, 2005	Z-1404-05	—	terminated	Users of these cassettes may detect poor film to screen contact and unsatisfactory sharpness of radiographic images.
Nov 25, 2003	Z-0207-04	—	terminated	The GS1 circuit board may fail resulting in smoke or fire.