FDA recall Z-0923-2026

AGFA Healthcare Corp. · Class II · device

Product

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

U.S. Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2025-11-18
Report date: 2025-12-31
Voluntary/Mandated: FDA Mandated
Location: Greenville, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0923-2026