Public recall detail

Selenia Dimensions 2D/3D Mammography Systems

2026-06-10

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Health products Health product recall
Quick summary

Quick summary: Selenia Dimensions 2D/3D Mammography Systems. Reason: Health product recall. Category: Health products. Date: 2026-06-10.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Selenia Dimensions 2D/3D Mammography Systems. Reason: Health product recall. Category: Health products. Date: 2026-06-10.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandHologic, Inc.
ProductSelenia Dimensions 2D/3D Mammography Systems
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82194

Affected products

ProductSelenia Dimensions 2D/3D Mammography System - 3D Main Unit
LotMore than 10 numbers, contact manufacturer.
ModelSDM-SYS-6000-3D-V19
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSelenia Dimensions 2D/3D Mammography System - 3D Main Unit
ProductSelenia Dimensions 2D/3D Mammography System - 3D Main Unit
LotMore than 10 numbers, contact manufacturer.
ModelSDM-00001-3D
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSelenia Dimensions 2D/3D Mammography System - 3D Main Unit
ProductSelenia Dimensions 2D/3D Mammography System - 3D Main Unit
LotMore than 10 numbers, contact manufacturer.
ModelSDM-SYS-9000-3D
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSelenia Dimensions 2D/3D Mammography System - 3D Main Unit
ProductSelenia Dimensions 2D/3D Mammography System - 3D Main Unit
LotMore than 10 numbers, contact manufacturer.
ModelSDM-05000-3D3
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSelenia Dimensions 2D/3D Mammography System - 3D Main Unit
ProductSelenia Dimensions 2D/3D Mammography System - 3D Main Unit
LotMore than 10 numbers, contact manufacturer.
ModelSDM-05000-3DC
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSelenia Dimensions 2D/3D Mammography System - 3D Main Unit
ProductSelenia Dimensions 2D/3D Mammography System - 3D Main Unit
LotMore than 10 numbers, contact manufacturer.
ModelSDM-05000-3D2
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSelenia Dimensions 2D/3D Mammography System - 3D Main Unit
ProductSelenia Dimensions 2D/3D Mammography System - 3D Main Unit
LotMore than 10 numbers, contact manufacturer.
ModelSDM-SYS-9000-3D-V19
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSelenia Dimensions 2D/3D Mammography System - 3D Main Unit
ProductSelenia Dimensions 2D/3D Mammography System - 3D Main Unit
LotMore than 10 numbers, contact manufacturer.
ModelSDA-SYS-3000-3D-V19
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSelenia Dimensions 2D/3D Mammography System - 3D Main Unit
ProductSelenia Dimensions 2D/3D Mammography System - 3D Main Unit
LotMore than 10 numbers, contact manufacturer.
ModelSDM-SYS-6000-3D
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSelenia Dimensions 2D/3D Mammography System - 3D Main Unit
ProductSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
LotMore than 10 numbers, contact manufacturer.
ModelSDM-05000-2DC
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
ProductSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
LotMore than 10 numbers, contact manufacturer.
ModelASY-06073
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
ProductSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
LotMore than 10 numbers, contact manufacturer.
ModelSDA-SYS-3000-2D
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
ProductSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
LotMore than 10 numbers, contact manufacturer.
ModelSDM-05000-2A3
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
ProductSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
LotMore than 10 numbers, contact manufacturer.
ModelSDA-SYS-3000-2D-V19
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
ProductSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
LotMore than 10 numbers, contact manufacturer.
ModelSDM-05000-2A2
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
ProductSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
LotMore than 10 numbers, contact manufacturer.
ModelSDM-SYS-6000-2D
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
ProductSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
LotMore than 10 numbers, contact manufacturer.
ModelSDM-SYS-9000-2D
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
ProductSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
LotMore than 10 numbers, contact manufacturer.
ModelSDM-05000-2AC
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
ProductSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
LotMore than 10 numbers, contact manufacturer.
ModelSDM-05000-2D3
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
ProductSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
LotMore than 10 numbers, contact manufacturer.
ModelSDM-SYS-6000-2D-V19
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
ProductSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
LotMore than 10 numbers, contact manufacturer.
ModelSDM-00001-2D
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
ProductSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
LotMore than 10 numbers, contact manufacturer.
ModelSDM-05000-2D2
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
ProductSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
LotMore than 10 numbers, contact manufacturer.
ModelSMD-SYS-6000-2D-HTC
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
ProductSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
LotMore than 10 numbers, contact manufacturer.
ModelSDM-SYS-9000-2D-V19
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSelenia Dimensions 2D/3D Mammography System - 2D Main Unit
ProductSystem
LotMore than 10 numbers, contact manufacturer.
Model3DM-SYS-INTL2D-NS-V2
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSystem
ProductSystem
LotMore than 10 numbers, contact manufacturer.
Model3DM-SYS-INTL3D
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSystem
ProductSystem
LotMore than 10 numbers, contact manufacturer.
Model3DM-SYS-INTL3D-MOB
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSystem
ProductSystem
LotMore than 10 numbers, contact manufacturer.
Model3DM-SYS-INTL2D
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSystem
ProductSystem
LotMore than 10 numbers, contact manufacturer.
Model3DM-SYS-INTL2D-V20
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSystem
ProductSystem
LotMore than 10 numbers, contact manufacturer.
Model3DM-SYS-STD-MOB
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSystem
ProductSystem
LotMore than 10 numbers, contact manufacturer.
Model3DM-SYS-INTL2D-MOB
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSystem
ProductSystem
LotMore than 10 numbers, contact manufacturer.
Model3DM-SYS-STD-MOB-V20
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSystem
ProductSystem
LotMore than 10 numbers, contact manufacturer.
Model3DM-SYS-STD-NS-V20
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSystem
ProductSystem
LotMore than 10 numbers, contact manufacturer.
Model3DM-SYS-INTL2D-NS
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSystem
ProductSystem
LotMore than 10 numbers, contact manufacturer.
Model3DM-SYS-INTL3D-NS
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSystem
ProductSystem
LotMore than 10 numbers, contact manufacturer.
Model3DM-SYS-STD-NS
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSystem
ProductSystem
LotMore than 10 numbers, contact manufacturer.
Model3DM-SYS-INTL2D-MOB-V2
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSystem
ProductSystem
LotMore than 10 numbers, contact manufacturer.
Model3DM-SYS-STD-V20
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSystem
ProductSystem
LotMore than 10 numbers, contact manufacturer.
Model3DM-SYS-STD
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSystem
ProductSystem
LotMore than 10 numbers, contact manufacturer.
Model3DM-SYS-INTL3D-NS-V20
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSystem
ProductSystem
LotMore than 10 numbers, contact manufacturer.
Model3DM-SYS-INTL3D-V20
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSystem
ProductSystem
LotMore than 10 numbers, contact manufacturer.
Model3DM-SYS-INTL3D-MOB-V20
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSystem

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Radiology
CompaniesHologic, Inc.600 Technology Drive, Newark, Delaware, United States, 19702
Recall date2026-04-22
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82194
Background{}
CompaniesHologic, Inc.600 Technology Drive, Newark, Delaware, United States, 19702
AudiencesHealthcare
Source updated2026-06-10

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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