Z-0923-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 31, 2025
- Initiation Date
- November 18, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 35
Product Description
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
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 Pattern
U.S. Nationwide distribution.
Code Information
N/A