The Recall Desk

Manufacturer

Agfa Healthcare NV

3 recalls in our database name Agfa Healthcare NV as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2024-10-16

Of the 3 recalls from Agfa Healthcare NV we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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.

1–3 of 3

  • HighFDA (Devices)·Z-0055-2025·2024-10-16

    Enterprise Imaging XERO Viewer medical software reference line placement error

    Enterprise Imaging XERO Viewer incorrectly displays reference lines on medical images due to a software defect affecting images with non-square pixel spacing. The misplaced reference lines may lead to diagnostic errors.

    Product
    Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data . Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8.1, 8.1.1, 8.1.2, 8.1.3,8.1.4, 8.2.0.000, 8.2.1.000, 8.2.2.000, 8.3.0.000, 8.3.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1004-2023·2023-02-01

    Agfa HealthCare XERO Viewer Medical Imaging Software Class II Defect

    Agfa Healthcare has recalled XERO Viewer imaging software due to a software defect that can cause issues with images. The defect affects approximately 110 units distributed across the US and 19 other countries.

    Product
    Agfa HealthCare Enterprise Imaging XERO Viewer
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0101-2019·2018-10-17

    Agfa Healthcare Recalls Enterprise Imaging Desktops Due to Sorting Error

    Agfa Healthcare is recalling 17 Enterprise Imaging Desktops because adding a comparison study may disrupt the chronological sorting of images in the Clinical Side Bar.

    Product
    Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a departmental Picture Archiving and Communications System (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, s
    Category
    Medical Device
    Distribution
    10 states