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Agfa N.V. recalls AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthe
Recalled March 25, 2020 · FDA recall Z-1502-2020 · Agfa N.V
Hazard
Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures. · FDA Class II
Units
2 units
Sold at
US Nationwide distribution in the states of FL, VA.
Description
Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.
Product
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
Manufacturer(s)
Agfa N.V.
Made in
Belgium
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →