Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
This recall is currently active, issued December 22, 2025. It was issued by Agfa Healthcare Corp..
- Company
- Agfa Healthcare Corp.
- Recall Initiated
- November 18, 2025
- Posted
- December 22, 2025
- Recall Number
- Z-0923-2026
- Quantity
- 35
- Firm Location
- Greenville, SC
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
U.S. Nationwide distribution.
Root Cause
Radiation Control for Health and Safety Act
Action Taken
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."