The Recall Desk
SevereFDA (Devices)·Z-2167-2026·Announced 2026-05-20

Hologic Selenia Dimensions Mammography Systems Loose Internal Bolts

Hologic has recalled Selenia Dimensions Mammography Systems because internal bolts may become loose, missing, or broken over time. The company has received complaints of this issue affecting systems nationwide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall of a medical imaging device. Class II recalls indicate a situation where use of or exposure to the product will cause or may cause serious adverse health consequences or death, and the agency's classification directly maps to a Severe (4) rating.

Plain-English summary

Hologic, Inc. is recalling Selenia Dimensions Mammography Systems across multiple model numbers distributed nationwide in the United States. The systems are affected because internal bolts may develop loose, missing, or broken conditions over time.

Complaints have been received of systems developing loose, missing, or broken internal bolts. The FDA classified this as a Class II recall. Healthcare facilities using affected models should contact Hologic for guidance on inspection and remediation steps.

The recalled product

Product
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-0
Manufacturer
Hologic, Inc
Category
Medical Device — Mammography Systems
Hazard
  • structural-defect
  • equipment-malfunction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • "Model No.
  • UDI": [SDA-SYS-3000-2D-HTC
  • 15420045510616]
  • [SDA-SYS-3000-3D
  • 15420045517783]
  • [SDM-SYS-6000-2D
  • 15420045510753]
  • [SDM-SYS-6000-3D
  • 15420045510760]
  • [SDM-00001-2D
  • 15420045510623]
  • [SDM-00001-3D
  • 15420045510630]
  • [SDM-00001-M2D
  • 15420045510647]
  • [SDM-00001-M3D
  • 15420045510654]
  • [SDM-05000-2A2
  • 15420045510661]
  • [SDM-05000-2A3

Distribution

Distributed nationwide across the United States.