FDA DevicesClass II
3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MO...
Published: May 20, 2026Recall ID: Z-2168-2026Category: devicesCountry: US
Reason for Recall / Hazard
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Product Description & Identification
3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD, 3DM-SYS-STD-MOB, 3DM-SYS-STD-NS.
Additional Source Details
| Field | Value |
|---|---|
| City | Marlborough |
| State | MA |
| Event id | 98566 |
| Address 1 | 250 Campus Dr |
| Code info | "[Model No.; UDI]: [3DM-SYS-INTL2D;15420045510609], [3DM-SYS-INTL2D-MOB;15420045510593], [3DM-SYS-INTL2D-NS;15420045510586], [3DM-SYS-INTL3D;15420045510579], [3DM-SYS-INTL3D-MOB;15420045510562], [3DM-SYS-INTL3D-NS;15420045510555], [3DM-SYS-STD;15420045510524], [3DM-SYS-STD-MOB;15420045510531], [3DM-SYS-STD-NS;15420045510548]; All Serial No. |
| Postal code | 01752-3020 |
| Report date | 20260520 |
| Product type | Devices |
| Product quantity | 14837 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.