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Selenia dimensions 2d 3d mammography systems

Official notice

10 Jun 2026

MediumHealth Canada

An official Health Canada notice concerns Selenia dimensions 2d 3d mammography systems. 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. Published 2026-06-10.

What to do now

Contact the manufacturer if you require additional information.

Recall number

82194

Official notice

2026-06-10

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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Skus

SDM-SYS-6000-3D-V19, SDM-00001-3D, SDM-SYS-9000-3D, SDM-05000-3D3, SDM-05000-3DC, SDM-05000-3D2, SDM-SYS-9000-3D-V19, SDA-SYS-3000-3D-V19, SDM-SYS-6000-3D, SDM-05000-2DC, ASY-06073, SDA-SYS-3000-2D, SDM-05000-2A3, SDA-SYS-3000-2D-V19, SDM-05000-2A2, SDM-SYS-6000-2D, SDM-SYS-9000-2D, SDM-05000-2AC, SDM-05000-2D3, SDM-SYS-6000-2D-V19, SDM-00001-2D, SDM-05000-2D2, SMD-SYS-6000-2D-HTC, SDM-SYS-9000-2D-V19, 3DM-SYS-INTL2D-NS-V2, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-V20, 3DM-SYS-STD-MOB, 3DM-SYS-INTL2D-MOB, 3DM-SYS-STD-MOB-V20, 3DM-SYS-STD-NS-V20, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD-NS, 3DM-SYS-INTL2D-MOB-V2, 3DM-SYS-STD-V20, 3DM-SYS-STD, 3DM-SYS-INTL3D-NS-V20, 3DM-SYS-INTL3D-V20, 3DM-SYS-INTL3D-MOB-V20

Other

RA RA-82194

Model Numbers

SDM-SYS-6000-3D-V19, SDM-00001-3D, SDM-SYS-9000-3D, SDM-05000-3D3, SDM-05000-3DC, SDM-05000-3D2, SDM-SYS-9000-3D-V19, SDA-SYS-3000-3D-V19, SDM-SYS-6000-3D, SDM-05000-2DC, ASY-06073, SDA-SYS-3000-2D, SDM-05000-2A3, SDA-SYS-3000-2D-V19, SDM-05000-2A2, SDM-SYS-6000-2D, SDM-SYS-9000-2D, SDM-05000-2AC, SDM-05000-2D3, SDM-SYS-6000-2D-V19, SDM-00001-2D, SDM-05000-2D2, SMD-SYS-6000-2D-HTC, SDM-SYS-9000-2D-V19, 3DM-SYS-INTL2D-NS-V2, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-V20, 3DM-SYS-STD-MOB, 3DM-SYS-INTL2D-MOB, 3DM-SYS-STD-MOB-V20, 3DM-SYS-STD-NS-V20, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD-NS, 3DM-SYS-INTL2D-MOB-V2, 3DM-SYS-STD-V20, 3DM-SYS-STD, 3DM-SYS-INTL3D-NS-V20, 3DM-SYS-INTL3D-V20, 3DM-SYS-INTL3D-MOB-V20

Recall Numbers

82194

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Affected products

Product 1

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - SDM-SYS-6000-3D-V19

Product 2

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - SDM-00001-3D

Product 3

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - SDM-SYS-9000-3D

Product 4

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - SDM-05000-3D3

Product 5

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - SDM-05000-3DC

Product 6

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - SDM-05000-3D2

Product 7

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - SDM-SYS-9000-3D-V19

Product 8

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - SDA-SYS-3000-3D-V19

Product 9

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - SDM-SYS-6000-3D

Product 10

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - SDM-05000-2DC

Product 11

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - ASY-06073

Product 12

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - SDA-SYS-3000-2D

Product 13

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - SDM-05000-2A3

Product 14

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - SDA-SYS-3000-2D-V19

Product 15

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - SDM-05000-2A2

Product 16

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - SDM-SYS-6000-2D

Product 17

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - SDM-SYS-9000-2D

Product 18

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - SDM-05000-2AC

Product 19

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - SDM-05000-2D3

Product 20

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - SDM-SYS-6000-2D-V19

Product 21

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - SDM-00001-2D

Product 22

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - SDM-05000-2D2

Product 23

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - SMD-SYS-6000-2D-HTC

Product 24

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - SDM-SYS-9000-2D-V19

Product 25

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 3DM-SYS-INTL2D-NS-V2

Product 26

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 3DM-SYS-INTL3D

Product 27

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 3DM-SYS-INTL3D-MOB

Product 28

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 3DM-SYS-INTL2D

Product 29

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 3DM-SYS-INTL2D-V20

Product 30

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 3DM-SYS-STD-MOB

Product 31

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 3DM-SYS-INTL2D-MOB

Product 32

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 3DM-SYS-STD-MOB-V20

Product 33

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 3DM-SYS-STD-NS-V20

Product 34

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 3DM-SYS-INTL2D-NS

Product 35

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 3DM-SYS-INTL3D-NS

Product 36

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 3DM-SYS-STD-NS

Product 37

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 3DM-SYS-INTL2D-MOB-V2

Product 38

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 3DM-SYS-STD-V20

Product 39

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 3DM-SYS-STD

Product 40

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 3DM-SYS-INTL3D-NS-V20

Product 41

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 3DM-SYS-INTL3D-V20

Product 42

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 3DM-SYS-INTL3D-MOB-V20

Risk / 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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Manufacturer

Not provided

Phone

Not provided

Brand: Hologic.

Source & status

Source

Health Canada

Tier

beta

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

82194

Classification

Type II

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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