CLASS II ONGOING Device recall · Reported 31 Dec 2025 · FDA Enforcement Report

Brand name: Agfa Digital Radiography X- Ray system DR recalled

Agfa Healthcare is recalling Brand name: Agfa Digital Radiography X- Ray system DR 800 with Musica, distributed nationwide in the US. The recall was initiated on 18 Nov 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesN/A

Quantity recalled35

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0923-2026
FDA event ID: 98101
Recalling firm: Agfa Healthcare, Greenville, SC
Classification: Class II
Status: Ongoing
Recall initiated: 18 Nov 2025
FDA classified: 22 Dec 2025
Reported: 31 Dec 2025
Type: FDA Mandated
Customers notified by: N/A
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

18 Nov 2025	Recall initiated by company
22 Dec 2025	Classified by FDA	+34 days
31 Dec 2025	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

U.S. Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

N/A

Where was it sold?

U.S. Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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