Hologic Selenia Dimensions 2D/3D Mammography Systems Recall 2026

Health Canada has posted a voluntary field safety corrective action issued by Hologic, Inc. affecting its Selenia Dimensions 2D/3D Mammography Systems and 3Dimensions Mammography Systems. The recall, identified under Health Canada identification number RA-82194, was initiated on April 22, 2026, and concerns a mechanical defect in the vertical travel assembly that could lead to uncommanded c-arm motion during clinical use, posing a risk to both patients and healthcare personnel.

What Products Are Being Recalled?

The recall covers a wide range of Selenia Dimensions and 3Dimensions mammography system models, including both 2D and 3D main units as well as integrated system configurations. Affected model numbers include but are not limited to:

• 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

Lot and serial numbers for all affected products exceed 10 entries per model; healthcare facilities are advised to contact the manufacturer directly to confirm whether their specific unit is included.

Why Was This Recall Issued?

Hologic initiated this voluntary field safety corrective action because the vertical travel assembly on the affected mammography systems may experience internal bolt failure over time. The vertical travel assembly uses eight internal bolts to secure the c-arm to the assembly. When one or more bolts become loose, go missing, or break, the device may exhibit shaking, vibration, or uncommanded c-arm motion during operation. Such uncontrolled movement of the c-arm during a mammography procedure presents a potential hazard to patients undergoing imaging as well as to the clinical staff operating the equipment. Health Canada has classified this recall as Type II, indicating that the use of the affected device may cause temporary adverse health consequences, and that the probability of serious adverse health consequences is remote.

Who Is Affected?

This recall is directed at the healthcare audience — specifically hospitals, breast imaging clinics, radiology departments, and any other medical facilities in Canada currently operating Hologic Selenia Dimensions or 3Dimensions mammography systems under one of the affected model numbers. Patients who have undergone or are scheduled for mammography examinations using these systems should speak with their healthcare provider if they have concerns. The issuing company, Hologic, Inc., is headquartered at 600 Technology Drive, Newark, Delaware, United States.

What Should You Do?

• Healthcare professionals and facility managers should immediately check whether their mammography system model number appears on the list of affected products.
• Because more than 10 serial numbers are associated with each model, contact Hologic, Inc. directly to verify if your specific unit is included in this recall.
• Follow any field safety corrective action instructions provided by Hologic representatives, including inspection and servicing of the vertical travel assembly.
• Do not continue use of a unit that exhibits shaking, vibration, or uncommanded c-arm motion until it has been inspected and cleared by a qualified Hologic service technician.
• Contact Hologic, Inc. at their Newark, Delaware office or through your regional Hologic service representative for further guidance and to arrange an inspection or repair.
• Report any adverse events or device malfunctions related to this issue to Health Canada through the official reporting channel at: https://www.canada.ca/en/services/health/report-health-safety-concern.html

Official Statement

According to the recall notice published by Health Canada on June 10, 2026: ‘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.’ The recall is classified as a Type II health product recall under identification number RA-82194, published by Health Canada under the category of Health Products — Medical Devices — Radiology.