FDA DevicesClass II
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-...
Published: May 20, 2026Recall ID: Z-2167-2026Category: devicesCountry: US
Reason for Recall / Hazard
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Product Description & Identification
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, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D.
Additional Source Details
| Field | Value |
|---|---|
| City | Marlborough |
| State | MA |
| Event id | 98566 |
| Address 1 | 250 Campus Dr |
| 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. |
| Postal code | 01752-3020 |
| Report date | 20260520 |
| Product type | Devices |
| Product quantity | 4,305 units |
| Reason for recall | Complaints have been received of systems developing loose, missing, or broken internal bolts over time. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260408 |
| Initial firm notification | Letter |
| Center classification date | 20260512 |
Overview
- Recalling FirmHologic, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution.