Hologic, Inc: 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,

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: 14837 units Lot/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.

UPC codes

15420045510609, 15420045510593, 15420045510586, 15420045510579, 15420045510562, 15420045510555, 15420045510524, 15420045510531, 15420045510548

Source

Official record: FDA (Device enforcement) ↗

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