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    Suros ATEC 0912-20 Breast Biopsy and Excision System Handpiece, REF ATEC0912-12, sterile, Hologic, Inc. 6100 Technology Center Drive Indianapolis, IN. The handpiece is inserted into the breast to the site of interest. When the proper location/position is acheived, the handpiece cuts and removes biopsy tissue.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code KNW·August 11, 2010

    Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers Software

    FDA Recall
    Terminated ·Hologic, Inc.·Product code KGI·September 24, 2008

    Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code JAA·April 25, 2013

    Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code JAA·April 25, 2013

    ATEC Breast Biopsy and Excision System 12 gauge, 20 centimeter handpiece, sterile, Hologic, Inc., Indianapolis, IN; Model number ATEC 1212-20. Intended for partial or complete removal of tissue samples for diagnostic testing.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code KNW·September 22, 2008

    Hologics SecurView DX workstation, software version 7.3.0 intended for viewing mammography images and other imaging modalities. SecurView DX is intended for selection, display, manipulation, filing and media interchange of multimodality images from a variety of different modality systems. It also interfaces to various image storage and printing devices, using DICOM or similar interface standards. The device used with FDA-cleared monitors may be used by a trained physician for display, manipulation, and interpretation of lossless compressed or non-compressed mammographic images for screening and diagnostic mammography, as well as any other DICOM multimodality image.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code LLZ·February 28, 2012

    Fluoroscan Mini C-arm, Models: FSIII, FSIIIC and Officemate The Officemate, FSIII and FSIIIc are compact mobile fluoroscopic C-arm systems specifically designed for x-ray imaging of extremities. The systems are used by trained medical personnel, but at times are used for non medical applications. The functionality of the units is identical for the OfficeMate, FSIII and FSIIIc. Also the construction of the different models is identical. That includes the mounting of the flex arm to the cabinet and the flex arm to the C-arm. The difference between the models resides in the monitors: " Officemate has one small monitor " FSIII has two larger monitors " FSIIIc is an international version of the FSIII (power kit)

    FDA Recall
    Terminated ·Hologic, Inc.·Product code JAA·July 21, 2011

    Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·February 5, 2016

    Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code JAA·September 14, 2012

    Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code MUE·May 13, 2014

    Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing.

    FDA Recall
    Open, Classified ·Hologic, Inc·Product code NSU·February 26, 2021

    ThinPrep CytoLyt Solution. Buffered Cell Wash Solution.

    FDA Recall
    Open, Classified ·Hologic, Inc·Product code LEA·December 12, 2025

    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 Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics System with the Genius" Cervical AI Algorithm cleared under DEN210035.

    FDA Recall
    Open, Classified ·Hologic, Inc·Product code QYV·March 23, 2026

    Hologic Explorer Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code KGI·June 27, 2008

    NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Number: RFC2009 Product Usage: The NovaSure Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in premenopausal women with mehorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.

    FDA Recall
    Terminated ·Hologic, Inc·Product code MNB·January 24, 2014

    Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14

    FDA Recall
    Open, Classified ·Hologic, Inc·Product code KNW·May 2, 2023

    Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q

    FDA Recall
    Terminated ·Hologic, Inc.·Product code LKV·November 29, 2017

    BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x 5cm 2) F0404 BioZorb Marker 4cm x 4cm 3) F0331 BioZorb Marker 1cm x 3cm x 3cm 4) F0231 BioZorb Marker 1cm x 3cm x 2cm 5) F0221 BioZorb Marker 1cm x 3cm x 2cm 6) F0304 BioZorb Marker 3cm x 4cm 7) F0303 BioZorb Marker 3cm x 3cm 8) F0203 BioZorb Marker 2cm x 3cm 9) F0202 BioZorb Marker 2cm x 2cm

    FDA Recall
    Open, Classified ·Hologic, Inc·Product code NEU·March 13, 2024

    Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as follows Model/Catalog Number: 1. ASY-16824 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.1 SYSTEMS 2. ASY-16825 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.2.1 SYSTEMS 3. ASY-17219 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.10.0 SYSTEMS 4. ASY-17220 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.1.0 SYSTEMS 5. ASY-17221 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.0 SYSTEMS 6. ASY-17222 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.2.0 SYSTEMS 7. 3DM-LIC-SW-UP-V2.3 DIMENSIONS SOFTWARE 2.3 (3DIMENSIONS) 8. SDM-LIC-SW-UP-V1.12 DIMENSION SOFTWARE 1.12 (SELENIA DIMENSIONS)

    FDA Recall
    Open, Classified ·Hologic Inc·Product code OTE·August 19, 2024

    Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101

    FDA Recall
    Completed ·Hologic, Inc·Product code FZX·October 10, 2022