Agfa Corp.
Greenville, SC
This page shows every FDA and USDA recall linked to Agfa Corp.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
57
Total Recalls
2003
First Recall
2014
Most Recent
AGFA Digital Radiography X-Ray system DX-D 100
Agfa's DX-D 100 is indicated for use in providing diagnostic q...
Jul 21, 2014
· Device
Terminated
IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Se...
May 27, 2014
· Device
Terminated
IMPAX RIS QDOC 5.8
Feb 3, 2014
· Device
Terminated
IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (P...
Oct 21, 2013
· Device
Terminated
AGFA Digital Radiography X-Ray System DX-D 100
Agfa's DX-D 100 is indicated for use in providing diagnostic q...
Jun 6, 2013
· Device
Terminated
IMPAX CV 7.8 SU3 - OCR Service.
The IMPAX CV Reporting component facilitates the quick , effective creation o...
Apr 8, 2013
· Device
Terminated
IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting.
Facilitates digital report...
Apr 8, 2013
· Device
Terminated
CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained i...
Mar 19, 2013
· Device
Terminated
AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Ser...
Aug 22, 2012
· Device
Terminated
IMPAX Cardiovascular (CV) Reporting
Reporting tool used for structured reporting and structured report output...
Aug 10, 2012
· Device
Terminated
IMPAX CV Reporting
The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective...
Jul 24, 2012
· Device
Terminated
Agfa DX-D Imaging Package - (The detector power cables described in the Report of Correction and Removal are c...
Feb 19, 2012
· Device
Terminated
Agfa Computed Radiography Systems with DX-G Digitizer.
DX-G Digitizers haved the same intended use as the pre...
Jan 11, 2012
· Device
Terminated
Curix Opthos H, size 35x43 cm
A radiographic medical x-ray film designed to optimize diagnostic chest imaging...
Nov 25, 2011
· Device
Terminated
IMPAX CardioVascular (CV) Admin Tool
The IMPAX Cardiovascular suite is a cardiovascular information system pr...
Nov 23, 2011
· Device
Terminated
IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR)
The IMPAX Cardiovascular suite is a...
Nov 18, 2011
· Device
Terminated
IMPAX Cardiovascular Results Management (RM) Software Versions RM 2.04.37.04 to RM 7.8 SU2
The IMPAX Cardiova...
Nov 18, 2011
· Device
Terminated
IMPAX CV (Cardio Vascular)
The IMPAX Cardiovascular suite is a cardiovascular information system, providing a...
Jun 10, 2011
· Device
Terminated
IMPAX 6.5 Client Software.
IMPAX 6.5 combines the traditional activities of RIS informatics management with P...
May 24, 2011
· Device
Terminated
NX is the radiographer's image identification and quality control tool. It offers a broad array of features de...
May 4, 2011
· Device
Terminated
IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8
Mar 16, 2011
· Device
Terminated
IMPAX CV Results Manager/Results Manager Administration Tool
The IMPAX Cardiovascular suite is a cardiovascul...
Feb 25, 2011
· Device
Terminated
Cardiovascular Review Station
The IMPAX Cardiovascular suite is a cardiovascular information system, providin...
Feb 24, 2011
· Device
Terminated
Mammography Keypad
Radiologists and Technologist apply hotkeys from a keyboard for ease of use in their clinic...
Dec 29, 2010
· Device
Terminated
DX-G Digitizer, manufactured by Agfa-Gevart NV, Mortsel, Belgium.
Nov 26, 2010
· Device
Terminated
IMPAX CV Results Manager/Results Manager Administration Tool
Jul 29, 2010
· Device
Terminated
19" Barco MFCD 1219 (Touch Screen) + Low Profile Stand and Rack with LCD Arm
Agfa's Computed Radiography Syst...
Jul 26, 2010
· Device
Terminated
DT2 Mammo, Size 8 x 10 inch, Ref No. E2RN6. Agfa Corporation. Greenville, SC 29601.
Intended to display mammo...
Jun 11, 2010
· Device
Terminated
Drystar Mammo.
Display of Mammographic images.
Mar 2, 2010
· Device
Terminated
AGFA IMPAX HeartStation ECG Management System.
Nov 18, 2009
· Device
Terminated
Agfa Impax R6.3 DB Server.
Impax Systems are Picture Archiving and Communication systems (PACs). PAC systems...
Sep 8, 2009
· Device
Terminated
NX 2008 Central Monitoring System (CMS). Product code: E2FB6
Agfa's Computed Radiography Systems with NX Wo...
Sep 2, 2009
· Device
Terminated
IMPAX Cardiovascular Polling Procedure version 1.00.09, used in IMPAX 6.2.1 and 6.3.1.; Catalog numbers: E18R4...
Feb 3, 2009
· Device
Terminated
Drystar AXYS, Hardcopy Printer
A free standing device used to print diagnostic conventional and mammography i...
Sep 18, 2008
· Device
Terminated
WEB1000 Versions 3.1, 4.1 and 5.1, Picture Archiving and Communications systems (PACs), used in the acceptance...
Sep 11, 2008
· Device
Terminated
IMPAX 6.2.1 System, Picture Archiving and Communications system (PAC), used in the acceptance, transfer, displ...
Sep 11, 2008
· Device
Terminated
IMPAX 4.1, IMPAX 4.5, IMPAX 5.0, IMPAX 5.1 IMPAX 5.2, IMPAX 6.0, IMPAX 6.2; Picture Archiving and Commun...
Sep 11, 2008
· Device
Terminated
Impax 6.x Clients including: 6.3 all versions below 6.3.1 SU5, 6.2 all versions below 6.2.1 SU14 and 6.0 all v...
Sep 4, 2008
· Device
Terminated
Impax 4.5, Impax 5.0, Impax 5.2 and Impax 5.2x Picture Archiving Systems (PACs) with integrated Voxar 3D soft...
Jul 2, 2008
· Device
Terminated
IMPAX 6.2.1 Network Gateway Server, License Key. Catalog # ABC code: EXEGE000. The product is used to trans...
Jul 1, 2008
· Device
Terminated
Agfa HeartLab Cardiovascular DICOMstore Version 2.04.40.00 software, Heartlab, Inc., Westerly, Rhode...
Jun 27, 2008
· Device
Terminated
Agfa Heartlab Cardiovascular Results Management Product: Versions 2.03 and 2.04. Heartlab, Inc., Westerly, R...
Jun 27, 2008
· Device
Terminated
Agfa IMPAX CardioVascular Suite Results Management Nuclear Reporting Module, Outbound Report, Model/Catalog No...
Mar 31, 2008
· Device
Terminated
CR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402 and NX 1.0.2405).
Nov 28, 2006
· Device
Terminated
CR DX-S, Image Intensified Fluoroscopic X-ray system.
Oct 12, 2006
· Device
Terminated
IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)
Oct 12, 2006
· Device
Terminated
IMPAX 4.5 Systems, used in the acceptance, transfer, display, storage and digital processing of medical images...
Jul 27, 2006
· Device
Terminated
CR DX-S, DX-S, Computed radiography system (Digitizer)
May 9, 2006
· Device
Terminated
Mamoray HDR-C PLUS Mammography film
Apr 22, 2006
· Device
Terminated
Curix Ultra UV-L Plus, Medical Screen Film, X-ray Film, 14x17, 100 Sheet Box
Apr 11, 2006
· Device
Terminated