Recall MonitorHealth Products
Selenia Dimensions 2D/3D Mammography Systems
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Radiology
Product: Selenia Dimensions 2D/3D Mammography Systems
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Selenia Dimensions 2D/3D Mammography System - 3D Main Unit | More than 10 numbers, contact manufacturer. | SDM-SYS-6000-3D-V19 |
| Selenia Dimensions 2D/3D Mammography System - 3D Main Unit | More than 10 numbers, contact manufacturer. | SDM-00001-3D |
| Selenia Dimensions 2D/3D Mammography System - 3D Main Unit | More than 10 numbers, contact manufacturer. | SDM-SYS-9000-3D |
| Selenia Dimensions 2D/3D Mammography System - 3D Main Unit | More than 10 numbers, contact manufacturer. | SDM-05000-3D3 |
| Selenia Dimensions 2D/3D Mammography System - 3D Main Unit | More than 10 numbers, contact manufacturer. | SDM-05000-3DC |
| Selenia Dimensions 2D/3D Mammography System - 3D Main Unit | More than 10 numbers, contact manufacturer. | SDM-05000-3D2 |
| Selenia Dimensions 2D/3D Mammography System - 3D Main Unit | More than 10 numbers, contact manufacturer. | SDM-SYS-9000-3D-V19 |
| Selenia Dimensions 2D/3D Mammography System - 3D Main Unit | More than 10 numbers, contact manufacturer. | SDA-SYS-3000-3D-V19 |
| Selenia Dimensions 2D/3D Mammography System - 3D Main Unit | More than 10 numbers, contact manufacturer. | SDM-SYS-6000-3D |
| Selenia Dimensions 2D/3D Mammography System - 2D Main Unit | More than 10 numbers, contact manufacturer. | SDM-05000-2DC |
| Selenia Dimensions 2D/3D Mammography System - 2D Main Unit | More than 10 numbers, contact manufacturer. | ASY-06073 |
| Selenia Dimensions 2D/3D Mammography System - 2D Main Unit | More than 10 numbers, contact manufacturer. | SDA-SYS-3000-2D |
| Selenia Dimensions 2D/3D Mammography System - 2D Main Unit | More than 10 numbers, contact manufacturer. | SDM-05000-2A3 |
| Selenia Dimensions 2D/3D Mammography System - 2D Main Unit | More than 10 numbers, contact manufacturer. | SDA-SYS-3000-2D-V19 |
| Selenia Dimensions 2D/3D Mammography System - 2D Main Unit | More than 10 numbers, contact manufacturer. | SDM-05000-2A2 |
| Selenia Dimensions 2D/3D Mammography System - 2D Main Unit | More than 10 numbers, contact manufacturer. | SDM-SYS-6000-2D |
| Selenia Dimensions 2D/3D Mammography System - 2D Main Unit | More than 10 numbers, contact manufacturer. | SDM-SYS-9000-2D |
| Selenia Dimensions 2D/3D Mammography System - 2D Main Unit | More than 10 numbers, contact manufacturer. | SDM-05000-2AC |
| Selenia Dimensions 2D/3D Mammography System - 2D Main Unit | More than 10 numbers, contact manufacturer. | SDM-05000-2D3 |
| Selenia Dimensions 2D/3D Mammography System - 2D Main Unit | More than 10 numbers, contact manufacturer. | SDM-SYS-6000-2D-V19 |
| Selenia Dimensions 2D/3D Mammography System - 2D Main Unit | More than 10 numbers, contact manufacturer. | SDM-00001-2D |
| Selenia Dimensions 2D/3D Mammography System - 2D Main Unit | More than 10 numbers, contact manufacturer. | SDM-05000-2D2 |
| Selenia Dimensions 2D/3D Mammography System - 2D Main Unit | More than 10 numbers, contact manufacturer. | SMD-SYS-6000-2D-HTC |
| Selenia Dimensions 2D/3D Mammography System - 2D Main Unit | More than 10 numbers, contact manufacturer. | SDM-SYS-9000-2D-V19 |
| System | More than 10 numbers, contact manufacturer. | 3DM-SYS-INTL2D-NS-V2 |
| System | More than 10 numbers, contact manufacturer. | 3DM-SYS-INTL3D |
| System | More than 10 numbers, contact manufacturer. | 3DM-SYS-INTL3D-MOB |
| System | More than 10 numbers, contact manufacturer. | 3DM-SYS-INTL2D |
| System | More than 10 numbers, contact manufacturer. | 3DM-SYS-INTL2D-V20 |
| System | More than 10 numbers, contact manufacturer. | 3DM-SYS-STD-MOB |
| System | More than 10 numbers, contact manufacturer. | 3DM-SYS-INTL2D-MOB |
| System | More than 10 numbers, contact manufacturer. | 3DM-SYS-STD-MOB-V20 |
| System | More than 10 numbers, contact manufacturer. | 3DM-SYS-STD-NS-V20 |
| System | More than 10 numbers, contact manufacturer. | 3DM-SYS-INTL2D-NS |
| System | More than 10 numbers, contact manufacturer. | 3DM-SYS-INTL3D-NS |
| System | More than 10 numbers, contact manufacturer. | 3DM-SYS-STD-NS |
| System | More than 10 numbers, contact manufacturer. | 3DM-SYS-INTL2D-MOB-V2 |
| System | More than 10 numbers, contact manufacturer. | 3DM-SYS-STD-V20 |
| System | More than 10 numbers, contact manufacturer. | 3DM-SYS-STD |
| System | More than 10 numbers, contact manufacturer. | 3DM-SYS-INTL3D-NS-V20 |
| System | More than 10 numbers, contact manufacturer. | 3DM-SYS-INTL3D-V20 |
| System | More than 10 numbers, contact manufacturer. | 3DM-SYS-INTL3D-MOB-V20 |
Issue
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.