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    Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The ceiling type x-ray tube support CH-200 is used to hold the X-ray tube and collimator to position the X-ray tube unit. This unit is used for radiographic examinations of whole body except mammography when combined with an X-ray high voltage generator, an X-ray tube unit, an X-ray collimator, and if necessary, an X-ray radiography stand, an X-ray radiography table, and digital radiography system.

    FDA Recall
    Open, Classified ·SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku·Product code IYB·October 16, 2025

    Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion.

    FDA Recall
    Terminated ·Medisystems a NX Stage Company·Product code FIE·December 20, 2012

    Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device in hemodialysis or other extracorporeal procedures. It is intended for use in conjunction with a blood tubing set equipped with a standard medical male luer-locking connector

    FDA Recall
    Terminated ·Medisystems a NX Stage Company·Product code FIE·December 20, 2012

    Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair.

    FDA Recall
    Terminated ·On-X Life Technologies, Inc.·Product code PAW·December 13, 2016

    On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33

    FDA Recall
    Open, Classified ·On-X Life Technologies, Inc.·Product code LWQ·February 1, 2026

    Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

    FDA Recall
    Terminated ·NOX MEDICAL Keldnaholt Reykjavik Iceland·Product code MNR·September 7, 2021

    Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES

    FDA Recall
    Open, Classified ·Vortex Surgical Inc.·Product code KDD·December 16, 2025

    X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage generator, an X-ray tube unit, an Image intensifier and X-ray television unit, this table is applied for the following X-ray examinations: -X-ray T.V. fluoroscopy -Spot-filming -Bucky radiography

    FDA Recall
    Terminated ·Shimadzu Medical Systems·Product code IXR·March 31, 2016

    BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01

    FDA Recall
    Terminated ·Medtronic·Product code FCG·February 8, 2017

    BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01

    FDA Recall
    Terminated ·Medtronic·Product code FCG·February 8, 2017

    The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table.

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code OWB·November 15, 2023

    Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. The ANX 3.0 system is comprised of these components. 1. Patient Physiological Monitor, 2. Laptop Computer, 3. Stand w/wheels, 4. Patient cables, 5. Software components (Respiratory and Cardiac Spectral Frequency Signal Processor). The different monitor components that can be used in the system are one of the following per system are as follows: Patient Physiological Monitors used: CJPS Vital Pro, Zoe Medical Nightingale Monitoring system, Ivy Biomedical model 405P, Software components: Ansar ANS C 3000. The device is also referred to as the ANS-C3000.

    FDA Recall
    Terminated ·Ansar Group, Inc. Dba Ansar Medical Technologies, Inc·Product code DRT·July 1, 2014

    Precedence SPECT/CT System, Precedence 16 3/8, Upper Patient Pallet, A single photon nuclear medicine and image from an X-ray computed tomography system, Model Number: 4535 602 50851, Catalog Number: 882350, Product is manufactured by Philips Medical Systems (Cleveland), Inc. Cleveland, OH Intended use: A single photon nuclear medicine and image from an X-ray computed tomography system.

    FDA Recall
    Terminated ·Phillips Nuclear Medicine·Product code INQ·January 26, 2009

    First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.

    FDA Recall
    Open, Classified ·First Source Inc·Product code IZL·May 9, 2024

    First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.

    FDA Recall
    Open, Classified ·First Source Inc·Product code IZL·May 9, 2024

    Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 10860700

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·July 2, 2024

    LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 11574100

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·July 2, 2024

    Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762472

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·July 2, 2024

    Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762471

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·July 2, 2024

    Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code MQB·May 12, 2014