AGFA Healthcare Corp. recalls Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name
- Recalling company
- AGFA Healthcare Corp.
- Product
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Nov 18, 2025
- Reported
- Dec 31, 2025
- Distribution
- U.S. Nationwide distribution.
- Status
- Ongoing
- Quantity
- 35
- Lot / codes
- N/A
- Company location
- Greenville, SC
- Recall type
- FDA Mandated
- Recall number
- Z-0923-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0923-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.