The Recall Desk

Manufacturer

AGFA Healthcare Corp.

12 recalls in our database name AGFA Healthcare Corp. as the manufacturing or recalling firm.

What the numbers show

Total
12
Critical
0
Severe
0
Most recent
2025-12-31

Of the 12 recalls from AGFA Healthcare Corp. 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.

1–12 of 12

  • HighFDA (Devices)·Z-0923-2026·2025-12-31

    Digital radiography systems recalled over exceeding the maximum air kerma rate

    AGFA Healthcare is recalling 35 DR 800 X-ray systems because it is possible to exceed the maximum allowed air kerma rate of 88mGy/min for pulsed fluoroscopy exams.

    Product
    Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2735-2017·2017-07-26

    Agfa Healthcare Recalls NX 3.0.8950 Imaging Processing Software

    Agfa Healthcare is recalling NX 3.0.8950 software because it may temporarily display and transmit incorrect patient images to PACS systems.

    Product
    Agfa Healthcare NX 3.0.8950 Imaging Processing Software
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Devices)·Z-2652-2017·2017-07-05

    AGFA Healthcare Recalls IMPAX Cardiovascular Software Due to Incorrect Findings

    AGFA Healthcare Corp. is recalling 10 units of IMPAX Cardiovascular software because it displayed incorrect aneurysm findings in NIV reports.

    Product
    IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1698-2017·2017-04-05

    AGFA DX-D100 X-Ray System Recalled for Missing Allen Wrench Storage Instructions

    AGFA Healthcare Corp. is recalling 308 DX-D100 Digital Radiography X-Ray Systems because the user manual did not specify where to store the Allen wrench used for manual movement.

    Product
    AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-0283-2016·2015-11-25

    Agfa Healthcare Recalls IMPAX CV Software for Incorrect PDF Reports

    Agfa Healthcare is recalling IMPAX CV software versions 7.8.x and 12.x because the Demographics Manager feature may generate incorrect PDF reports after physician signature.

    Product
    IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Number in previously signed reports that have since changed.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-2061-2015·2015-07-22

    Agfa Healthcare Recalls Two IMPAX Agility Medical Imaging Systems

    Agfa Healthcare is recalling two IMPAX Agility PACS units in Missouri due to a software error that displayed incorrect patient names.

    Product
    IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, repor
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1745-2015·2015-06-17

    AGFA DX-D 100 Mobile X-Ray System Recalled for Unintended Movement

    AGFA Healthcare Corp. is recalling 233 mobile digital radiography x-ray systems due to a risk of sporadic unintended movements caused by electrostatic discharge.

    Product
    AGFA DX-D 100 is a mobile digital radiography x-ray system
    Category
    Medical Device
    Distribution
    29 states
  • LowFDA (Devices)·Z-0804-2015·2014-12-24

    AGFA Healthcare Recalls Radiomat M+ NIF Films Due to Coating Artifacts

    AGFA Healthcare is recalling 142 units of Radiomat M+ NIF films because the coating may show small bright thin lines when processed.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2175-2014·2014-08-20

    Agfa Healthcare Recalls DX-D 600 Imaging Packages Due to Crane Movement

    Agfa Healthcare is recalling 17 DX-D 600 imaging packages because the overhead tube crane may move uncontrolled. Customers should stop using the equipment.

    Product
    DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extr
    Category
    Medical Device
    Distribution
    9 states
  • LowFDA (Devices)·Z-2176-2014·2014-08-20

    Agfa Digital Radiography X-Ray System Recalled for Mislabeled Output Power

    AGFA Healthcare Corp. is recalling one Agfa Digital Radiography X-Ray System DX-D 100 unit in West Virginia because it was mislabeled with a factory label showing 32 KW output power.

    Product
    Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2178-2014·2014-08-20

    Agfa Healthcare Recalls Radiographic Film Due to Fogged Sheets

    Agfa Healthcare is recalling specific lots of radiographic film because some sheets are fogged, which may affect image quality.

    Product
    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 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists
    Category
    Medical Device
    Distribution
    Distributed nationwide