DR 400 5520/100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414904176252), received between Jan 3, 2025 and Jul 30, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 30, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  A CUSTOMER IN THE US REPORTED THE COLLIMATOR FELL OFF A DR 400 SYSTEM WHILE THE CUSTOMER WAS ROTATING THE COLLIMATOR. THE LOCAL AGFA FIELD SERVICE ENGINEER RESPONDED AND CONFIRMED A PORTION OF THE RESIN FLANGE WAS BROKEN. A NEW COLLIMATOR AND METAL FLANGE WAS INSTALLED. PER THE CUSTOMER REQUEST A SYSTEM PREVENTIVE MAINTENANCE (PM) WAS ALSO PERFORMED. THE SYSTEM IS NOW WORKING AS INTENDED AND THERE HAVE BEEN NO ADDITONAL EVENTS REPORTED. THERE WAS NO REPORTED HARM TO USER OR PATIENTS AND THERE ARE NO FUTURE ACTIONS RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22670830 ↗
• MalfunctionJan 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER IN GERMANY REPORTED THE COLLIMATOR FELL OFF A DR 400 SYSTEM. THE CUSTOMER WAS TURNING THE TUBE FROM THE TABLE TO THE WALLSTAND AND THE PLASTIC FLANGE BROKE AND THE COLLIMATOR FELL FROM THE SYSTEM. THE LOCAL AGFA FIELD SERVICE ENGINEER WAS AT THE CUSTOMER SITE COMPLETING AN UNRELATED SERVICE AND WAS ABLE TO REVIEW THE BROKEN FLANGE. THE LOCAL SERVICE ENGINEER REPLACED THE BROKEN FLANGE AND REATTACHED THE SYSTEM COLIMATOR. 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 21069400 ↗