Recall Z-0923-2026— AGFA Healthcare Corp.

Name: FDA recall Z-0923-2026
Creator: U.S. Food and Drug Administration
Published: 2025-11-18

Class II · Ongoing

Class II FDA medical device recall by AGFA Healthcare Corp., initiated 2025-11-18. It names one FDA 510(k) clearance: K183275. 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..

Recalling firm: AGFA Healthcare Corp.
Classification: Class II
Status: Ongoing
Initiated: 2025-11-18
Firm location: Greenville, SC, United States

510(k) clearances named in this recall

1 on FDA's record

K183275 — DR 800 with TomosynthesisAgfa N.V.·cleared 2019-02-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.