FDAApril 8, 2026device
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-050...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
What to do
FDA enforcement status: Ongoing
Brands named
hologic
UPCs
154200455106161542004551778315420045510753154200455107601542004551062315420045510630154200455106471542004551065415420045510661154200455106781542004551068515420045510692
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDA3DIMENSIONS 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.2026-04-08
- FDABrand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics System with the Genius...2026-03-23
- FDABrand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No2026-02-18
- FDABrevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.2025-12-15
- FDAThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.2025-12-12
- FDABrand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A2025-01-15
- FDAThe Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The Collection Tube (PN: 71550-001) is manufactured by a third-party supplier, MML Diagnostics Packaging, and includes the transport tube, cap, and extraction buffer. Tu...2025-01-08
- FDAPanther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.2024-12-13
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