Agfa N.V. recalls AGFA Digital Radiography X- Ray system DR 800 with TomoSynth
Recalled 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
Hazard / Issue
Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.
Issued by
FDA
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