Agency classClass IIOur severity:Severe FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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…
Manufacturer: Hologic, Inc
Category: Medical Device — Mammography Systems
Hazard: structural-defect
equipment-malfunction
Affected units: 4,305

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.

Part of a larger recall action

This product is one of 2 recalled by Hologic, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Hologic, Inc

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