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AGFA Healthcare Recalls
12 recalls on record · August 20, 2014 to December 31, 2025 · Medical Devices
Recalls by year
14
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17
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 31, 2025Medical DevicesFDA
AGFA Healthcare Corp. recalls Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Hazard: 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.
July 26, 2017Medical DevicesFDA
AGFA Healthcare Corp. recalls Agfa Healthcare NX 3.0.8950 Imaging Processing Software
Hazard: 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.
July 5, 2017Medical DevicesFDA
AGFA Healthcare Corp. recalls IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allow
Hazard: 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.
April 12, 2017Medical DevicesFDA
AGFA Healthcare Corp. recalls DX-D600 - DXD Imaging Package
Hazard: One of the dent markers from the DX-D600 dropped down from the overhead rail.
April 5, 2017Medical DevicesFDA
AGFA Healthcare Corp. recalls AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to ai
Hazard: 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.
November 25, 2015Medical DevicesFDA
AGFA Healthcare Corp. recalls IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic
Hazard: 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.
July 22, 2015Medical DevicesFDA
AGFA Healthcare Corp. recalls IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provi
Hazard: 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.
June 17, 2015Medical DevicesFDA
AGFA Healthcare Corp. recalls AGFA DX-D 100 is a mobile digital radiography x-ray system
Hazard: When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur.
December 24, 2014Medical DevicesFDA
AGFA Healthcare Corp. recalls Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat M+ NIF 25,4CM x 30,5CM
Hazard: Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed.
August 20, 2014Medical DevicesFDA
AGFA Healthcare Corp. recalls Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8
Hazard: Some sheets of the medical screen film are fogged.
August 20, 2014Medical DevicesFDA
AGFA Healthcare Corp. recalls Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality i
Hazard: Unit was mislabeled with a factory label showing 32 KW output power.
August 20, 2014Medical DevicesFDA
AGFA Healthcare Corp. recalls DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to aid the p
Hazard: Some customers reported that while using the DX-D600 in room or exam preparation, the Overhead Tube Crane (OTC) showed increased velocity and uncontrolled longitudinal movement.