Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Hologic, Inc or your healthcare provider for instructions. Notification method: Letter
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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.. Reason: Complaints have been received of systems developing loose, missing, or broken internal bolts over time.. Classification: Class II. Quantity: 4,305 units. Distribution: US Nationwide distribution.
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Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
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