Agfa N.V. recalls AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynth…
- Recall date
- February 10, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1502-2020
- FDA classification
- Class II
- Brand / firm
- Agfa N.V.
- Sold / distributed
- US Nationwide distribution in the states of FL, VA.
Why it was recalled
Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications
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