FDA recall Z-1502-2020

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

Reason for recall

Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.

Distribution

US Nationwide distribution in the states of FL, VA.

Key facts

Status

Terminated

Initiation date

2020-02-10

Report date

2020-03-25

Termination date

2023-03-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mortsel, Belgium

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1502-2020