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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: "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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Hologic, Inc
- Reason for Recall:
- Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
"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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2167-2026
Related Recalls
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