AGFA Healthcare Corp.: Device Recall
Recall #Z-0923-2026 · 11/18/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0923-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- AGFA Healthcare Corp.
- Status
- Ongoing
- Date Initiated
- 11/18/2025
- Location
- Greenville, SC, United States
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 35
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.
Product Description
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Distribution Pattern
U.S. Nationwide distribution.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.