Agfa Healthcare Corp.

• Enterprise Imaging Desktops 8.1.1 Ref 8.1.1

  Class II FDA UDI

• Enterprise Imaging XERO Viewer 8.1.1 Ref 8.1.1

  Class II FDA UDI

• Impax 6.7 Ref IMPAX 6.7

  Class II FDA UDI

• Impax 6 Ref 6

  Class II FDA UDI Active

• IMPAX Clinical Applications 4 Ref 4

  Class II FDA UDI Active

• Enterprise Imaging Desktops 8.1.2 Ref 8.1.2

  Class II FDA UDI

• Enterprise Imaging Xero Viewer 8.1 Ref Enterprise Imaging Xero Viewer 8.1

  Class II FDA UDI

• Enterprise Imaging Desktops 8.1 Ref Enterprise Imaging Desktops 8.1

  Class II FDA UDI

• Enterprise Imaging XERO Viewer 8.1.2 Ref 8.1.2

  Class II FDA UDI

• Orthogon Ref K073271

  Class II FDA 510(k) Active

• Impax Se Sigmacom Client (Pacs Workstation) Ref K071297

  Class II FDA 510(k) Active

• Agfa Computed Radiography System With NX2.X Workstations Ref K071162

  Class II FDA 510(k) Active

• Impax MA3000 Diagnostic Pacs Workstation Ref K081976

  Class II FDA 510(k) Active

• Drystar Axys, Model EYZ4E Ref K072680

  Class II FDA 510(k) Active

• Registration And Fusion Ref K080013

  Class II FDA 510(k) Active

• Agfa Computed Radiography Systems With NX2008 Workstations Ref K081963

  Class II FDA 510(k) Active

• Orthopedic Software For Impax Workstations Ref K071972

  Class II FDA 510(k) Active

Showing the 10 most recent of 15 recalls.

• 2025

  • 18 Nov 2025 Z-0923-2026 Class II Ongoing 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.via FDA establishment Agfa HealthCare GmbH

• 2024

  • 6 Sep 2024 Z-0055-2025 Class II Ongoing Software defect, when an image has non-square pixel spacing, the reference/localizer line is incorrectly placed on the scout image in the XERO Viewet, may display the incorrect crosshair/line position on the non-coplanar/scout image with respect to the axial slice location. Inaccurate placement of reference lines or crosshairs have potential risk of misdiagnosis or mistreatment due to unintended shifts in the display of anatomical locations.via FDA establishment Agfa HealthCare GmbH

• 2022

  • 5 Dec 2022 Z-1004-2023 Class II Ongoing There is a software defect that can cause issues with images.via FDA establishment Agfa HealthCare GmbH

• 2018

  • 3 Aug 2018 Z-0101-2019 Class II Terminated Adding an additional comparison study to the Clinical Side Bar in the Enterprise Imaging Diagnostics Desktop, can result in a change of the sort order of the studies in the Clinical Side Bar. The thumbnail images of the studies are no longer chronologically sorted with the most recent study at the top.via FDA establishment Agfa HealthCare GmbH

• 2016

  • 22 Dec 2016 Z-2652-2017 Class II Terminated A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm.via FDA establishment Agfa HealthCare GmbH
  • 21 Dec 2016 Z-2735-2017 Class II Terminated A customer reported that when using an NX workstation with software version NX 3.0.8950 software and selecting the affected patient/exam from closed exams, initially the wrong image was linked to the exam and appeared. After a short time the wrong image was replaced by the correct image, however the wrong image was used for transmitting to PACS.via FDA establishment Agfa HealthCare GmbH
  • 2 May 2016 Z-1738-2017 Class II Terminated One of the dent markers from the DX-D600 dropped down from the overhead rail.via FDA establishment Agfa HealthCare GmbH
  • 20 Jan 2016 Z-1698-2017 Class II Terminated The DX-D100 User Manual already contained information about to move a DX-D100 mobile unit manually by using an Allen wrench, but did not indicate where the Allen wrench should be stored.via FDA establishment Agfa HealthCare GmbH

• 2015

  • 1 Sep 2015 Z-0283-2016 Class II Terminated Customers have experienced IMPAX CV software, specifically, Demographics Manager (DM), not producing correct pdf reports after the reports, at the time of physician signature, were correct.via FDA establishment Agfa HealthCare GmbH
  • 26 Jun 2015 Z-2061-2015 Class II Terminated Firm received a complaint that the hospital had sent two accession numbers over the same morning and on the Agility side the patient name was incorrect.via FDA establishment Agfa HealthCare GmbH

• Agfa Healthcare Inc. WATERLOO Ontario · CA FEI 3008794078
• Agfa HealthCare GmbH Vienna Wien · AT FEI 3009238185
• Agfa HealthCare NV Gent West-Vlaanderen · BE FEI 3009238175

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