Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common... recall (AGFA Healthcare Corp.)
Medical deviceClass IIOngoing
Summary: AGFA Healthcare Corp. is recalling Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800. Reason: 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 is being recalled
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
U.S. Nationwide distribution.
How to tell if yours is affected
N/A
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0923-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | November 18, 2025 |
| Reported | December 31, 2025 |
| Company | AGFA Healthcare Corp. |
| Company location | Greenville, SC, United States |
| Initiated by | FDA Mandated |
| Quantity | 35 |
More recalls from AGFA Healthcare Corp. · all medical device recalls · recalls from November 2025