AGFA Healthcare Corp.: Medical Device Recall in 2025 - (Recall #: Z-0923-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800

Product Classification:

Class II

Date Initiated: November 18, 2025

Date Posted: December 31, 2025

Recall Number: Z-0923-2026

Event ID: 98101

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.

Status: Ongoing

Product Quantity: 35

Code Information:

N/A

Distribution Pattern:

U.S. Nationwide distribution.

Voluntary or Mandated:

FDA Mandated