Selenia Dimensions 2D/3D Mammography Systems
Brand(s)
Last updated
Summary
Product
Selenia Dimensions 2D/3D Mammography Systems
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected 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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
| Hologic, Inc. |
| 600 Technology Drive, Newark, Delaware, United States, 19702 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82194
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