Brand name: AGFA Digital Radiography X- Ray system DR 800... (AGFA Healthcare Corp.) – it is possible to exceed the maximum ... (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Brand
AGFA Healthcare Corp.
Lot Codes / Batch Numbers
N/A
Products Sold
N/A
AGFA Healthcare Corp. is recalling Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800 due to 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 incre. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
AGFA NV notified Customers via a letter titled "IMPORTANT PRODUCT INFORMATION LETTER / DR 800", included Product Name, Symptom, Cause, Actions to be taken customer and manufacturers respectively: "Always enable ABS for pulsed fluoro exams. Actions being taken by the manufacturer: Agfa/local business partner will contact you to install a new generator software."
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026