The Recall Desk

Manufacturer

AGFA Corp.

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

What the numbers show

Total
11
Critical
0
Severe
0
Most recent
2014-07-30

Of the 11 recalls from AGFA 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.

1–11 of 11

  • ModerateFDA (Devices)·Z-2081-2014·2014-07-30

    AGFA DX-D 100 X-Ray System Recalled for Touch Screen Malfunction

    AGFA Corp. is recalling 216 DX-D 100 digital radiography systems because liquid contact with the touch screen may cause the device to incorrectly recognize user input and alter settings.

    Product
    AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 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, spi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1662-2014·2014-06-04

    AGFA Recalls IMPAX CV Pediatric Echo Reporting Software Due to Defect

    AGFA Corp. is recalling IMPAX CV Pediatric Echo Reporting software in South Carolina due to a known software defect in the OCR service.

    Product
    IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0035-2014·2013-10-30

    Agfa IMPAX 5.2 DB Server Software Recall for Performance Issues

    Agfa Corp. is recalling IMPAX 5.2 DB Server software because older versions may cause system downtime or slow performance in medical imaging systems.

    Product
    IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1487-2013·2013-06-12

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

    AGFA Corp. is recalling 104 DX-D 100 digital radiography systems because they may experience intermittent, unintended, and illogical movement during use.

    Product
    AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 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, spin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1069-2013·2013-04-17

    AGFA Recalls IMPAX CV 7.8 SU3 Software Due to Design Error

    AGFA Corp. is recalling IMPAX CV 7.8 SU3 software due to a design error. The product was distributed in Florida and Kentucky.

    Product
    IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive v
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1070-2013·2013-04-17

    AGFA IMPAX CV Software Recall for Incorrect Data Transfer

    AGFA Corp. is recalling 26 units of IMPAX CV software because baseline pulmonary capillary wedge pressure values were not correctly transferring into hospital electronic health records.

    Product
    IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0970-2013·2013-03-27

    Agfa X-Ray Image Plate Recall Due to Incorrect Barcode Labeling

    Agfa Corp. is recalling 17 X-ray image plates shipped with incorrect size barcodes, affecting facilities in 10 US states.

    Product
    CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in an X-Ray cassette, used to capture images from X-Ray exposures. The cassette with the image plate, once exposed, is inserted in the Agfa Digitizer CR 10-X where the ima
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2252-2012·2012-08-29

    AGFA Medical Image Storage Device Recall for Data Loss Risk

    AGFA Corp. is recalling IMPAC and IMPAX CV DICOMStore devices because misconfiguration may cause loss of patient data.

    Product
    AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2184-2012·2012-08-22

    AGFA IMPAX Cardiovascular Reporting Software Recalled for Missing Report Data

    AGFA Corp. is recalling IMPAX Cardiovascular Reporting software because user-entered conclusions were not printed on final reports.

    Product
    IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2069-2012·2012-08-01

    AGFA IMPAX CV Reporting Software Recalled for Incorrect Stenosis Display

    AGFA Corp. is recalling IMPAX CV Reporting software versions 2.03 to 2.08 because selecting 'Left stenosis' incorrectly displays 'Right stenosis' in printed reports.

    Product
    IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, pediatric echocardiography, congenital heat disease, nuclear cardiology and non
    Category
    Medical Device
    Distribution
    Distributed nationwide