Exact FDA event identifier

Event 98566

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: April 08, 2026
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Hologic, Inc

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D.

Z-2167-2026

Recall number: Z-2167-2026
Initiated: April 08, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Hologic, Inc
Quantity: 4,305 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

"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;15420045510678], [SDM-05000-2AC;15420045510685], [SDM-05000-2D2;15420045510692], [SDM-05000-2D3;15420045510708], [SDM-05000-2DC;15420045510715], [SDM-05000-3D2;15420045510722], [SDM-05000-3D3;15420045510739], [SDM-05000-3DC;15420045510746], [SDM-SYS-9000-2D;15420045510777], [SDM-SYS-9000-3D;15420045510784]; All Serial No.

Distribution pattern

US Nationwide distribution.

device · product 2 of 2

3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD, 3DM-SYS-STD-MOB, 3DM-SYS-STD-NS.

Z-2168-2026

Recall number: Z-2168-2026
Initiated: April 08, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Hologic, Inc
Quantity: 14837 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

"[Model No.; UDI]: [3DM-SYS-INTL2D;15420045510609], [3DM-SYS-INTL2D-MOB;15420045510593], [3DM-SYS-INTL2D-NS;15420045510586], [3DM-SYS-INTL3D;15420045510579], [3DM-SYS-INTL3D-MOB;15420045510562], [3DM-SYS-INTL3D-NS;15420045510555], [3DM-SYS-STD;15420045510524], [3DM-SYS-STD-MOB;15420045510531], [3DM-SYS-STD-NS;15420045510548]; All Serial No.

Distribution pattern

US Nationwide distribution.