FDA recall Z-1144-2023

Product

Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D SDM-05000-3DC SDM-SYS-6000-3D SDM-05000-2D3 SDA-SYS-3000-2D SDM-00001 SDM-SYS-9000-2D SDM-00001-M2D 3DM-SYS-STD 3DM-SYS-STD-NS SDM-05000-2AC SDM-05000-2A2 SDA-SYS-3000-3D SDA-SYS-3000-3D-UPS SDM-SYS-6000-3D-HTC SDM-05000-2D2 SDM-05000-3D2 SDM-SYS-6000-2D SDM-SYS-9000-3D

Reason for recall

C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2023-01-16

Report date

2023-03-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Danbury, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1144-2023