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    GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·September 29, 2023

    GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360009

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·September 29, 2023

    X-Guide Handpiece Adaptor Sleeve 3, Model P010727

    FDA Recall
    Open, Classified ·X-NAV Technologies, LLC·Product code QRY·March 4, 2024

    X-Guide Handpiece Adaptor Sleeve 1, Model P010701

    FDA Recall
    Open, Classified ·X-NAV Technologies, LLC·Product code QRY·March 4, 2024

    X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673

    FDA Recall
    Open, Classified ·X-NAV Technologies, LLC·Product code QRY·September 28, 2022

    ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011

    FDA Recall
    Open, Classified ·Inari Medical Oak Canyon·Product code QEW·July 19, 2024

    Artix MT Thrombectomy Device, REF: 32-102

    FDA Recall
    Open, Classified ·Inari Medical Oak Canyon·Product code QEW·April 8, 2025

    stryker Sage PrimaFit External Urine Management System for the Female Anatomy

    FDA Recall
    Open, Classified ·Sage Products Inc 3909 3 Oaks Rd Cary IL 60013-1804·Product code NZU·October 23, 2023

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 16 Power, Brilliance 16/10/6 Water/Air 728240/728245/728246 - Brilliance 16 728255/728256/728266 - Brilliance 6 728250/728251 - Brilliance 10 728260 - Extended Brilliance Workspace

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·May 1, 2021

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. BB (Big Bore) Oncology, BB (Big Bore) Radiology: 728242/728243/728244/728272 - Brilliance Big Bore

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·May 1, 2021

    Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS

    FDA Recall
    Open, Classified ·Covidien, LLC·Product code JAK·May 22, 2023

    Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148

    FDA Recall
    Open, Classified ·Philips North America·Product code JAK·April 25, 2023

    Incisive CT-Computed Tomography X-Ray System Model: 728143

    FDA Recall
    Open, Classified ·Philips North America·Product code JAK·April 25, 2023

    Spectral CT on Rails, Software Version 5.1.0, Model Number 728334

    FDA Recall
    Open, Classified ·Philips North America·Product code JAK·October 9, 2023

    The Oncology Essentials Package of the Spectral CT imaging system.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·March 29, 2024

    Canon Aquilion Prime, Model TSX-303A

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code JAK·March 25, 2019

    The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports components and accessories. This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. Further, the images can be post processed to produce additional imaging planes or analysis results. The system is indicated for head, whole body, cardiac, and vascular X-ray Computed Tomography applications. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code JAK·June 30, 2021

    Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 Always-On vTrack Universal Tracker, SM/CL, 12-18ga INS-5036 "22 UTW 125mm Always-On Tip Tracked Biopsy Needle, Trocar point" INS-5034 17 UTW Lg 123mm Always-On Tip Tracked Biopsy Needle, Chiba point 00815686020354 INS-5032 "19 UTW 150mm Always-On Tip Tracked Biopsy Needle, Chiba point" INS-5029 "19 UTW 105 mm Always-On Tip Tracked biopsy needle, Chiba oint" INS-5028 19 UTW 155 mm Always-On Tip Tracked biopsy needle, Chiba point INS-5024 "17ga 150mm Always-On Tip Tracked Biopsy Needle, Chiba point" INS-5023 17ga 100mm Always-On Tip Tracked Biopsy Needle, Chiba point INS-5017 17ga x 155mm Tip Tracked Bx Needle INS-5016 17ga x 155mm Tip Tracked Bx Needle

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code JAK·August 10, 2023

    GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems

    FDA Recall
    Open, Classified ·GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China·Product code JAK·November 5, 2024

    GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system

    FDA Recall
    Open, Classified ·GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China·Product code JAK·November 5, 2024