United StatesThe recall affects the AGFA Digital Radiography X‑Ray system DR 800 with MUSICA Dynamic (common name DR 800), distributed nationwide in the U.S.; 35 units are involved. It was recalled because the Air Kerma rate (AKR) for pulsed fluoroscopy can exceed the maximum allowed 88 mGy/min if the frame rate is increased on the NX workstation while ABS (automatic brightness/beam stabilization) is not enabled.
What's being recalled
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Recalling firm: AGFA Healthcare Corp., Greenville, SC, United States.
How to identify it
N/A
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S. Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)