The Recall Desk

Manufacturer

Agfa N.V.

7 recalls in our database name Agfa N.V. as the manufacturing or recalling firm.

What the numbers show

Total
7
Critical
0
Severe
1
Most recent
2024-09-04

Of the 7 recalls from Agfa N.V. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (14%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–7 of 7

  • HighFDA (Devices)·Z-1462-2024·2024-04-10

    Mobile X-ray System Structural Cable Defect Affects Safety Function

    Agfa DX-D 100 mobile X-ray systems have a structural cable defect in the support column that may prevent the safety mechanism from blocking the arm if the cable fails, potentially resulting in patient injury.

    Product
    Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generate projection X-Ray images of human patients. Models: 5411/ 050, A5411/ 0300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2202-2020·2020-06-10

    Agfa DR 800 X-Ray System Recalled for Dose Calculation Error

    Agfa N.V. is recalling 13 DR 800 digital radiography systems because a software error may cause incorrect dose calculations during specific fluoroscopic exams.

    Product
    AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product Usage: DR 800: Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures: positioning f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1502-2020·2020-03-25

    Agfa DR 800 X-Ray System Recalled for Tomosynthesis Sequence Error

    Agfa N.V. is recalling two DR 800 X-ray systems because the tomosynthesis image acquisition sequence did not stop automatically after the expected number of exposures.

    Product
    AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2056-2019·2019-08-07

    Agfa DR 800 Digital Radiography System Recalled for Image Mismatch

    Agfa N.V. is recalling four DR 800 digital radiography systems because the exposed area of fluoroscopic exams may not match the active detector area.

    Product
    AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following an anatomies/procedures: positioning fluoroscopy procedures,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1034-2019·2019-03-27

    Agfa Radiographic Film Recalled for Visible Pinholes in Images

    Agfa N.V. is recalling specific lots of PET Plates Coated Film-MONOMEDBV2S2 radiographic film because inhomogeneous coating solutions cause visible pinholes in images.

    Product
    PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: 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 show
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3245-2018·2018-10-03

    Agfa DX-D 600 X-Ray System Recalled for Potential Cable Failure

    Agfa N.V. is recalling 108 DX-D 600 X-ray systems because support cables may break, posing a risk of the equipment falling.

    Product
    DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton
    Category
    Medical Device
    Distribution
    Distributed nationwide