Recall
Get alerts

hologic, inc

5 recalls on record

Get alerts
H
Hologic, Inc — 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,

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

H
Hologic, Inc — 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

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

H
Hologic, Inc — Brand 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

It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings. Modifications included disabling Barco Application Appearance Manager (AAM), altering calibration and compliance parameters, and adjusting additional display-related settings. This field correction is being conducted to restore affected system to the validated configuration and reinforce proper use in accordance with the Operator's Manual.

H
Hologic, Inc — Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.

Presence of particulates in affected devices that can be deposited into breast tissue during use.

H
Hologic, Inc — ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.

Fungal contamination of affected lot with Parengyodontium album.