Health product recall

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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