Quick Facts at a Glance
- Recall Date
- November 18, 2025
- Hazard Level
- HIGH
- Brand
- AGFA Healthcare
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- AGFA Healthcare
- Product type
- Digital Radiography X-Ray System
- Model numbers
- N/A
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 18, 2025
Reported by FDA DEVICE
December 31, 2025
RecallRadar source check
January 7, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact AGFA Healthcare Corp. or your healthcare provider for instructions. Notification method: N/A
About This Product
The AGFA Digital Radiography X-Ray system DR 800 is used in medical facilities for imaging patients. It allows for advanced imaging techniques that improve diagnostic capabilities.
Why This Is Dangerous
The system may exceed the safe radiation levels during pulsed fluoroscopy exams if certain settings are not correctly configured, potentially exposing patients to harmful radiation.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must cease use of the device, which may disrupt imaging services until the issue is resolved.
Practical Guidance
How to identify if yours is affected
- Check the model number of your AGFA Digital Radiography X-Ray system to see if it is part of the recall.
- Review the settings on the NX workstation for framerate configurations.
- Contact AGFA Healthcare for confirmation if needed.
Where to find product info
Model numbers and other identifiers can typically be found on the back or sides of the device.
What timeline to expect
Expect a timeline of 4-6 weeks for refund processing once you contact AGFA Healthcare.
If the manufacturer is unresponsive
- Document all correspondence with AGFA Healthcare.
- Follow up with a phone call if you do not receive a response within a week.
- Consider filing a complaint with the FDA if unresolved.
How to prevent similar issues
- Look for FDA recalls when purchasing medical devices.
- Check for safety certifications before acquiring medical equipment.
- Ask for detailed information on the safety mechanisms of imaging devices.
Documentation advice
Keep records of your purchase, any correspondence with AGFA Healthcare, and documentation of the recall.
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Product Details
The recalled product is the AGFA Digital Radiography X-Ray system DR 800 with MUSICA Dynamic. It is classified as a Class II device and has a quantity of 35 units recalled. These systems were distributed nationwide in the U.S.
Key Facts
- Recall date: November 18, 2025
- Class II device
- Nationwide distribution in the U.S.
- Stop using the device immediately
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Safety Guide
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