⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

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

Medical DevicesSource: FDA (device) · Date: 2025-12-31

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
AGFA Healthcare Corp.
Product
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
U.S. Nationwide distribution.
Recall initiated
2025-11-18
Code info
N/A
Product quantity
35
Voluntary mandated
FDA Mandated
City
Greenville
State
SC
Country
United States
Event id
98101
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