BEUDAMED
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    Elekta, Apex add-on Micro MLC, collimator for radiation therapy.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IXI·January 18, 2013

    AD 7 Patient table supplied with Allura Xper FD10 and Allura Xper FD10/10. Product is non-tilting but can be purchased with a tilt option.

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code IXI·March 14, 2008

    DMLC IV-ERGO - Beam shaping block for Radiation Therapy.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IXI·August 15, 2013

    VS200 radiographic Cassette Holder or Wall Stand. For use in radiology department.

    FDA Recall
    Terminated ·Del Medical, Inc.·Product code IXY·December 3, 2015

    Axxent Flexishield Mini To shape the beam from a low energy radiation therapy source up to 50kVp.

    FDA Recall
    Terminated ·Xoft Inc.·Product code IXI·February 3, 2011

    Siemens mMLC (ModuLeaf) safety bar and trolley label. Siemens Medical Solutions USA, Inc. Concord, CA. The intended use of the Siemens branded mMLC is an accessory used with the Linear Accelerator systems to deliver x-ray photon and electron radiation for the therapeutic treatment of cancer. This accessory shapes the radiation beam, per the leaf parameters, to minimize the amount of dose to outlying tissue.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IXI·February 7, 2012

    DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so that adjacent non-diseased tissues are spared to the extent possible.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IXI·May 1, 2013

    Bucky Stand SU-4000 Input 2017.11.17. SU41711085 Date: 2017-11-17; Board Name; Board Version, Firmware Version Advanced Universal U-Arm 4000 System. The Positioner consists of the following associated subassemblies: Vertical Column, Swivel Arm with variable height, X-ray Tube, Automatic Exposure Control, Collimator, Touch Screen Control and Image Receptor Assembly. The Positioner and the Patient Mobile Table are associated equipment to the Generator X-ray Unit.

    FDA Recall
    Terminated ·Konica Minolta Healthcare, Americas, Inc.·Product code IXY·November 8, 2018

    The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated in a radiographic table. It is intended to be used in general radiographic applications as a component of a radiographic system.

    FDA Recall
    Terminated ·Claymount Assembli Anholtseweg 44 Dinxperlo Netherlands·Product code IXY·March 15, 2014

    The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated in a radiographic table.

    FDA Recall
    Terminated ·Claymount Assembli Anholtseweg 44 Dinxperlo Netherlands·Product code IXY·March 15, 2014

    VS300 radiographic Cassette Holder or Wall Stand. For use in radiology department.

    FDA Recall
    Terminated ·Del Medical, Inc.·Product code IXY·December 3, 2015

    EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0682001286, EDS Light Suspension, Central Axis, 5P/FP; 0682001298, EDS Light Suspension, Central Axis, 5P; 0682001299, EDS Light Suspension, Central Axis, 5P/5P; 0682001300, EDS Light Suspension, Central Axis, FP/5P/5P; 0682001432, EDS Light Suspension, Central Axis 9P/FP; 0682001433, EDS Light Suspension, Central Axis, 9P; 0682001434, EDS Light Suspension, Central Axis, 9P/5P; and 0682001435, EDS Light Suspension, Central Axis, FP/9P/5P. Product Usage: The lighting system is intended to illuminate the operative site during surgical procedures with high intensity light.

    FDA Recall
    Open, Classified ·Stryker Communications·Product code FSY·November 13, 2018

    The Stryker Visum LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light. Affected part numbers are 0682001432 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/FP), 0682001286 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/FP), 0682001298 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P), 0682001299 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/5P), 0682001300 (EDS LIGHT SUSPENSION, CENTRAL AXIS, FP/5P/5P), 0682001433 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P), 0682001434 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/5P), 0682001435 (EDS LIGHT SUSPENSION, CENTRAL AXIS, FP/9P/5P) Product Usage: The Stryker Visum LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light

    FDA Recall
    Terminated ·Stryker Communications·Product code FSY·February 28, 2017

    Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241

    FDA Recall
    Open, Classified ·Zimmer, Inc.·Product code PHX·May 20, 2026

    Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240

    FDA Recall
    Open, Classified ·Zimmer, Inc.·Product code PHX·May 20, 2026

    Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242

    FDA Recall
    Open, Classified ·Zimmer, Inc.·Product code PHX·May 20, 2026

    Gamma camera systems: AXIS SPECT Systems & IRIX SPECT Systems, Model #: AXIS- 882130, IRIX- 882140. Philips Healthcare. Used to do nuclear medicine diagnostic imaging of various body organs.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·November 18, 2011

    Portex Dual-Axis Swivel Adapter Catalog Number: 525151

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·September 9, 2004

    Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200)

    FDA Recall
    Terminated ·Product code NHX·November 11, 2005

    Fiberoptic Bronchoscope Dual-Axis Swivel Adapter Catalog Number: 625191

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·September 9, 2004