FDA Device

DX-G Digitizer, manufactured by Agfa-Gevart NV, Mortsel, Belgium.

Hazard

Packaging was switched between a DX-G Digitizer and a DX-M Digitizer, resulting in the wrong product, which is not sold in the US, being shipped to the consignee.

What You Should Do

Remedy

Agfa halted Installation of the incorrect unit, and the unit was sent to Agfa warehouse in Carlstadt, NJ, where it is being held in quarantine for export.

Products

DX-G Digitizer, manufactured by Agfa-Gevart NV, Mortsel, Belgium.
Brand
AGFA Corp.
UPC
Model 5170/100

Units Affected

One unit