Reported Dec 31, 2025 · Ongoing

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

AGFA Healthcare Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: AGFA Healthcare Corp. · 10 S Academy St · Greenville, SC · 29601-2632

Is this the product you have?

  • Brand nameAGFA Digital Radiography X- Ray system
  • DR 800 with MUSICA Dynamic Common NameDR 800
Lot codes and dates
  • N/A
Amount recalled
35

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:56 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.