Commercial name: Digital Mammography System - Amulet Innovality. Technical Name: Mammography Unit. ANVISA registration number: 80022060030. Risk class: III. Affected Model: (FDR-3500 DRLH). Affected serial numbers: 57220649, 66120660, 66220706, 66220707, 66220708, 66220709, 66420762, 66420763, 66720855, 66720856, 66720859, 66720860, 66720860, 66720861, 66720861, 67221038, 67221039, 67221040, 76421200, 76421202, 76421204