RegWardenFDA facility compliance records
Facility

AGFA N.V.

18 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2012: 3 recalls; 2013: 5 recalls; 2014: 3 recalls; 2018: 1 recalls; 2019: 2 recalls; 2020: 2 recalls; 2024: 2 recalls3’125’133’14’15’16’171’182’192’20’21’22’232’24’25’26
  • Recalls (18)

Devices registered here (1)

  • Solid State X-Ray Imager (Flat Panel/Digital Imager)
    Product code MQB (opens in a new tab) · Class II · Radiology · 21 CFR 892.1680

Recalls & enforcement

20242 records
  • Class IIOngoing2024-07-29
    Potential for the front lever chain of the DR 800 table to fail.
  • Class IIOngoing2024-02-23
    Steel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube head has potential risk -an interference could cause the safety system which blocks the arm if the cable is cut off does not work properly, may result in patient injury
20202 records
  • Class IITerminated2020-04-06
    Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible
  • Class IITerminated2020-02-10
    Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.
20192 records
  • Class IITerminated2019-06-27
    The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.
  • Class IIITerminated2019-01-25
    Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run shows pinholes in different frequencies and intensities
20181 record
  • Class IITerminated2018-08-15
    A supplier for the Agfa system noted a potential for the steel support cables of a similar device to break. This led to a mandatory review of all systems, changing the pulley and cables if any deterioration in the cables or irregular or excessive pulley wear. If the two cables th…
20143 records
  • Class IITerminated2014-06-06
    When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user input altering device settings.
  • Class IITerminated2014-04-30
    Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.
  • Class IITerminated2014-01-08
    Patient name displayed (printed) on the Patient Report was the wrong patient name.
20135 records
  • Class IITerminated2013-09-19
    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.
  • Class IITerminated2013-05-15
    Customers could potentially experience intermittent, unintended and illogical movement when using the product.
  • Class IITerminated2013-03-15
    Software design error in IMPAX CV 7.8 SU3
  • Class IITerminated2013-03-15
    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.
  • Class IITerminated2013-02-07
    The cassettes were shipped with the wrong IP (image plate) size bar code.
20123 records
  • Class IITerminated2012-08-09
    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).
  • Class IITerminated2012-07-27
    Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.
  • Class IITerminated2012-07-10
    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.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “AGFA N.V. (FEI 3001556265) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3001556265-agfa-n-v/

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