FDA-Device2020-03-25Class II
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
Agfa N.V.
Hazard
Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.
Sold states
US Nationwide distribution in the states of FL, VA.
Affected count
2 units
Manufactured in
Septestraat 27, Mortsel, Belgium
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1502-2020Don't want to check this manually?
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