CanadaSelenia Dimensions 2D/3D Mammography Systems (including 3D and 2D main units with model/catalogue numbers such as SDM-SYS-6000-3D-V19, SDM-00001-3D, SDM-SYS-9000-3D, SDM-05000-3D3, SDM-05000-3DC, SDM-05000-3D2, SDA-SYS-3000-3D-V19, SDM-SYS-6000-3D, SDM-05000-2DC, ASY-06073, SDA-SYS-3000-2D, SDM-05000-2A3) are affected. Hologic is initiating a voluntary field safety corrective action because the vertical travel assembly may experience internal bolt failure over time, which can cause shaking, vibration or uncommanded c-arm motion. Contact the manufacturer for additional information.
What's being recalled
Companies: Hologic, Inc., 600 Technology Drive, Newark, Delaware, United States, 19702.
How to identify it
Affected products: Selenia Dimensions 2D/3D Mammography System - 3D Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SDM-SYS-6000-3D-V19
Affected products: Selenia Dimensions 2D/3D Mammography System - 3D Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SDM-00001-3D
Affected products: Selenia Dimensions 2D/3D Mammography System - 3D Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SDM-SYS-9000-3D
Affected products: Selenia Dimensions 2D/3D Mammography System - 3D Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SDM-05000-3D3
Affected products: Selenia Dimensions 2D/3D Mammography System - 3D Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SDM-05000-3DC
Affected products: Selenia Dimensions 2D/3D Mammography System - 3D Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SDM-05000-3D2
Affected products: Selenia Dimensions 2D/3D Mammography System - 3D Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SDM-SYS-9000-3D-V19
Affected products: Selenia Dimensions 2D/3D Mammography System - 3D Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SDA-SYS-3000-3D-V19
Affected products: Selenia Dimensions 2D/3D Mammography System - 3D Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SDM-SYS-6000-3D
Affected products: Selenia Dimensions 2D/3D Mammography System - 2D Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SDM-05000-2DC
Affected products: Selenia Dimensions 2D/3D Mammography System - 2D Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: ASY-06073
Affected products: Selenia Dimensions 2D/3D Mammography System - 2D Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SDA-SYS-3000-2D
Affected products: Selenia Dimensions 2D/3D Mammography System - 2D Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SDM-05000-2A3
Affected products: Selenia Dimensions 2D/3D Mammography System - 2D Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SDA-SYS-3000-2D-V19
Affected products: Selenia Dimensions 2D/3D Mammography System - 2D Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SDM-05000-2A2
Affected products: Selenia Dimensions 2D/3D Mammography System - 2D Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SDM-SYS-6000-2D
Affected products: Selenia Dimensions 2D/3D Mammography System - 2D Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SDM-SYS-9000-2D
Affected products: Selenia Dimensions 2D/3D Mammography System - 2D Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SDM-05000-2AC
Affected products: Selenia Dimensions 2D/3D Mammography System - 2D Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SDM-05000-2D3
Affected products: Selenia Dimensions 2D/3D Mammography System - 2D Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SDM-SYS-6000-2D-V19
Affected products: Selenia Dimensions 2D/3D Mammography System - 2D Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SDM-00001-2D
Affected products: Selenia Dimensions 2D/3D Mammography System - 2D Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SDM-05000-2D2
Affected products: Selenia Dimensions 2D/3D Mammography System - 2D Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SMD-SYS-6000-2D-HTC
Affected products: Selenia Dimensions 2D/3D Mammography System - 2D Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SDM-SYS-9000-2D-V19
Affected products: System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 3DM-SYS-INTL2D-NS-V2
Affected products: System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 3DM-SYS-INTL3D
Affected products: System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 3DM-SYS-INTL3D-MOB
Affected products: System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 3DM-SYS-INTL2D
Affected products: System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 3DM-SYS-INTL2D-V20
Affected products: System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 3DM-SYS-STD-MOB
Affected products: System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 3DM-SYS-INTL2D-MOB
Affected products: System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 3DM-SYS-STD-MOB-V20
Affected products: System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 3DM-SYS-STD-NS-V20
Affected products: System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 3DM-SYS-INTL2D-NS
Affected products: System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 3DM-SYS-INTL3D-NS
Affected products: System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 3DM-SYS-STD-NS
Affected products: System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 3DM-SYS-INTL2D-MOB-V2
Affected products: System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 3DM-SYS-STD-V20
Affected products: System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 3DM-SYS-STD
Affected products: System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 3DM-SYS-INTL3D-NS-V20
Affected products: System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 3DM-SYS-INTL3D-V20
Affected products: System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 3DM-SYS-INTL3D-MOB-V20
The hazard
Hologic is initiating this voluntary field safety corrective action because the vertical travel assembly on 3Dimensions and Selenia Dimensions systems may experience internal bolt failure over time. The vertical travel assembly contains eight internal bolts that secure the c-arm to the assembly. Devices with loose, missing or broken bolts may exhibit shaking, vibration or uncommanded c-arm motion.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States