DX-D 100 5411/050Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414904094440), received between Jan 3, 2025 and Apr 22, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K103597); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2025Unintended System Motion; Unintended System Motion

  A CUSTOMER IN THE UNITED KINGDOM REPORTED UNINTENDED MOVEMENT OF A DX-D 100 SYSTEM. THE USER STATED THE SYSTEM WAS BEING MOVED WHEN IT ACCELERATED INTO A WALL AND BEGAN BEEPING. THERE WERE NO PATIENTS INVOLVED. THE LOCAL AGFA FIELD SERVICE ENGINEER RESPONDED TO INVESTIGATE THE ISSUE AND COMPLETED SEVERAL SYSTEM CHECKS. DURING THE INVESTIGATION, AGFA SERVICE REPLACED THE DMC BOARD AND THE SYSTEM WORKED AS INTENDED. THERE HAVE BEEN NO ADDITIONAL REPORTED EVENTS. AS PART OF THE DEVICE INVESTIGATION BY AGFA AND THE SUPPLIER, THE REMOVED BOARD WAS TESTED AND WORKED AS INTENDED. THE ROOT CAUSE FOR THE REPORTED EVENT IS UNKNOWN. THERE HAS BEEN NO REPORTED HARM TO PATIENT OR USERS FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21880089 ↗
• MalfunctionJan 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER IN AUSTRALIA REPORTED THE COLLIMATOR FELL OFF A DX-D 100 SYSTEM. THE LOCAL AGFA FIELD SERVICE ENGINEER RESPONDED AND CONFIRMED SCREWS ATTACHED TO THE COLLIMATOR ADJUSTMENT WERE LOOSE. THE LOCAL ENGINEER REATTACHED THE SYSTEM COLLIMATOR AND TIGHTENDED THE SCREWS. THERE WERE NO REPORTED INJURIES TO USER OR PATIENTS. THE SYSTEM IS NOW WORKING AS INTENDED AND THERE ARE NO FUTURE ACTIONS RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21069717 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103597. One submission often covers many models, so check the product and lot details in each record.

• Z-1462-2024 · Feb 23, 2024 · Open, Classified
  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 modalit
• Z-1698-2017 · Jan 20, 2016 · Terminated
  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
• Z-1745-2015 · May 29, 2015 · Terminated
  AGFA DX-D 100 is a mobile digital radiography x-ray system
• Z-2081-2014 · Jun 6, 2014 · Terminated
  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 use
• Z-2176-2014 · May 13, 2014 · Terminated
  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.
• Z-1487-2013 · May 15, 2013 · Terminated
  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