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Open, Classified

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

FDA Recall Z-0923-2026 · Posted 2025-12-22

Recalling FirmAGFA Healthcare Corp.
Recall StatusOpen, Classified
Product CodeIZF
Date Initiated2025-11-18
Product Quantity35

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.

Firm Action

AGFA NV notified Customers via a letter titled "IMPORTANT PRODUCT INFORMATION LETTER / DR 800", included Product Name, Symptom, Cause, Actions to be taken customer and manufacturers respectively: "Always enable ABS for pulsed fluoro exams. Actions being taken by the manufacturer: Agfa/local business partner will contact you to install a new generator software."

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

U.S. Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K183275DR 800 with TomosynthesisAgfa N.V. · 2019-02-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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