AGFA Recalls
11 recalls on record · August 1, 2012 to July 30, 2014 · Medical Devices
Recalls by year
12
13
14
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 30, 2014Medical DevicesFDA
AGFA Corp. recalls AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality i
Hazard: When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user input altering device settings.
June 4, 2014Medical DevicesFDA
AGFA Corp. recalls IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPA
Hazard: Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.
February 12, 2014Medical DevicesFDA
AGFA Corp. recalls IMPAX RIS QDOC 5.8
Hazard: Patient name displayed (printed) on the Patient Report was the wrong patient name.
October 30, 2013Medical DevicesFDA
AGFA Corp. recalls IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
Hazard: 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.
June 12, 2013Medical DevicesFDA
AGFA Corp. recalls AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality i
Hazard: Customers could potentially experience intermittent, unintended and illogical movement when using the product.
April 17, 2013Medical DevicesFDA
AGFA Corp. recalls IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for ca
Hazard: 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.
April 17, 2013Medical DevicesFDA
AGFA Corp. recalls IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digita
Hazard: Software design error in IMPAX CV 7.8 SU3
March 27, 2013Medical DevicesFDA
AGFA Corp. recalls CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in an X-Ray
Hazard: The cassettes were shipped with the wrong IP (image plate) size bar code.
August 29, 2012Medical DevicesFDA
AGFA Corp. recalls AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS
Hazard: 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).
August 22, 2012Medical DevicesFDA
AGFA Corp. recalls IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (inclu
Hazard: Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.
August 1, 2012Medical DevicesFDA
AGFA Corp. recalls IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating
Hazard: 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.