SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-60

FDA device recall Z-2167-2026 · posted 2026-05-12 · Open, Classified

Recall details

Recalling firm

Hologic, Inc

Reason for recall

Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

Action taken

On April 8, 2026 URGENT FIELD SAFETY NOTICE letters were sent to customers. Customers were informed of implementing an updated recurring maintenance inspection for detecting loosened, missing, or broken bolts within the VTA. Hologic Service will reach out to schedule your service appointment and perform the required inspection. Following the initial inspection, recurring inspections are required to be conducted at least every 6 months to ensure continued safe/proper operation of the system. Future inspections will consist of torque and visual confirmation that all bolts are present and that there is no indication of loosening. Actions: You may continue to use your 3Dimensions or Selenia Dimensions for its intended use. If at any time during system operation, you observe unexpected C-Arm movement, please discontinue use and contact Hologic s Technical Support immediately. Report suspected device complaints and/or adverse events to Hologic and the FDA (contact details below). After initial inspection by Hologic, it is required to have the inspection performed at least every 6 months as well as the other defined maintenance and service activities which are critical for continued safe and effective operation of the Selenia Dimensions or 3Dimensions system. Forward this notice to anyone in your facility that needs to be informed. Post a copy of this notice in a visible area near the affected devices where operators can view for awareness and please keep a copy for your records.

Root cause

Device Design

Status

Open, Classified

Product code

MUE

Quantity affected

4,305 units

Distribution

US Nationwide distribution.

Date initiated

2026-04-08

Date posted

2026-05-12

Location

Marlborough, MA