medical Class II Updated 2020-03-25

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

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: 00949, 1161
View official government recall

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