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    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

    FMI 105"Oral Surgery Administration Set; Item AMS-468-1 Manufactured For: First Medical inc., 8515 Douglas Ave., Suite 23 Urbandale, IA 50322 Intended use: Intravascular Administration Set

    FDA Recall
    Terminated ·Churchill Medical Systems, Inc.·Product code FPA·November 16, 2010

    Digital Radiography System Model DFP-8000D/FPD,

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code JAA·November 10, 2005

    Digital Radiography System Model DFP8000D

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code JAA·November 10, 2005

    The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system is a combination of a cardiac dedicated nuclear imaging subsystem and LightSpeed GE CT subsystem. This system is intended for cardiac Nuclear Medicine (NM) diagnostic imaging applications, head and body CT diagnostic imaging applications, as well as attenuation correction and anatomical localization. The Discovery product is a SPECT-CT system. It consists of two back-to-back gantries, the NM Gantry, carrying solid state Cadmium Zinc Telluride (CZT) detectors, the CT Gantry, a single patient table, power distribution unit (PDU), NMV integrated power supply (IPS) , two operator consoles with two acquisition systems (Nuclear and CT), interconnecting cables and associated accessories (ECG gating, etc.).

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code KPS·April 10, 2013

    Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995.

    FDA Recall
    Open, Classified ·Foundation Medicine, Inc.·Product code PQP·March 24, 2026

    Performix X-ray Tube - Performix ADV, Performix Ultra, Solarix 630.

    FDA Recall
    Terminated ·General Electric Med Systems·Product code IYB·December 8, 2003

    GE Healthcare CT Systems Table Model Number 2271242 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code JAK·March 12, 2009

    GE Healthcare CT Systems Table Model Number 2225283 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code JAK·March 12, 2009

    GE Healthcare CT Systems Table Model Number 2269165 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code JAK·March 12, 2009

    GE Healthcare Proteus XR/a General Purpose Radiographic System, Models 2259973-4 and 2380179 containing Proteus Operator Console model# 2259976.

    FDA Recall
    Terminated ·General Electric Med Systems LLC·Product code KPR·May 31, 2006

    GE Healthcare Innova 3100 and Innova 3100 with Bolus Chasing offered as an option, Cardiovascular Imaging System.

    FDA Recall
    Terminated ·GE Healthcare·Product code MQB·March 6, 2006

    GE Medical Systems Innova 2000 and Innova 2000S, and Innova 2000 and Innova 2000S mobile version. Cardiovascular Imaging System.

    FDA Recall
    Terminated ·GE Healthcare·Product code MQB·March 6, 2006

    Signa MFO/I Magnetic Resonance System, Model Numbers : 2210339, 2262700, 2276937, 2282853, 2282860, 2282880, 2352129, 2388781, 5105123, 5113339, 2138300-32, 2189500-3, 2198999-4, 2259620-4, 2262700-2, 2269512-2, 2286849-2, 2352129-2, 2377062-5, 2377062-8, Manufactured by GE Hangwei Medical Systems Co., LTD, Beijing PR, China

    FDA Recall
    Terminated ·GE Healthcare·Product code LNH·December 31, 2006

    GE Healthcare Innova 4100 and Innova 4100 with Bolus Chasing offered as an option. Digital Fluoroscopic Imaging System.

    FDA Recall
    Terminated ·GE Healthcare·Product code MQB·March 6, 2006

    Prestige SI

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAA·November 21, 2016

    Prestilix

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LLZ·November 21, 2016

    ADVANTX LCV+

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code IZI·November 21, 2016

    Prestige VH

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAA·November 21, 2016

    Innova 2000

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code OWB·November 21, 2016