Hologic, Inc: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, S

Hazard

Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

Details from the source

Reason for recall: Complaints have been received of systems developing loose, missing, or broken internal bolts over time. Distribution: US Nationwide distribution. Quantity: 4,305 units Lot/code info: "Model No.; UDI": [SDA-SYS-3000-2D-HTC;15420045510616], [SDA-SYS-3000-3D;15420045517783], [SDM-SYS-6000-2D;15420045510753], [SDM-SYS-6000-3D;15420045510760], [SDM-00001-2D;15420045510623], [SDM-00001-3D;15420045510630], [SDM-00001-M2D;15420045510647], [SDM-00001-M3D;15420045510654], [SDM-05000-2A2;15420045510661], [SDM-05000-2A3;15420045510678], [SDM-05000-2AC;15420045510685], [SDM-05000-2D2;15420045510692], [SDM-05000-2D3;15420045510708], [SDM-05000-2DC;15420045510715], [SDM-05000-3D2;15420045510722], [SDM-05000-3D3;15420045510739], [SDM-05000-3DC;15420045510746], [SDM-SYS-9000-2D;15420045510777], [SDM-SYS-9000-3D;15420045510784]; All Serial No.

UPC codes

15420045510616, 15420045517783, 15420045510753, 15420045510760, 15420045510623, 15420045510630, 15420045510647, 15420045510654, 15420045510661, 15420045510678, 15420045510685, 15420045510692, 15420045510708, 15420045510715, 15420045510722, 15420045510739, 15420045510746, 15420045510777, 15420045510784

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.