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    Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code JDX·June 4, 2019

    Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code JDX·June 4, 2019

    steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.

    FDA Recall
    Terminated ·Product code LLZ·November 29, 2013

    Villa Sistemi Rotograph EVO 3D X-ray

    FDA Recall
    Terminated ·Villa Radiology Systems LLC·Product code MUH·August 5, 2015

    Owandy Radiology I -MAX Touch 3D X-ray

    FDA Recall
    Terminated ·Villa Radiology Systems LLC·Product code OAS·August 5, 2015

    Medtronic TSRH 3DX Implant Set; SPS002058. Sets are unlabeled, but contain individually labeled 3Dx Splined Connectors in sizes small, medium and large. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions.

    FDA Recall
    Terminated ·Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK·Product code MNI·October 31, 2008

    ANSPACH - 7MM Extra Coarse Diamond Ball; REF M-7DX-G1 Cutting shaping bone including spine and cranium.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBE·April 13, 2015

    Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images and Xray projection images for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.

    FDA Recall
    Open, Classified ·Palodex Group Oy Nahkelantie 160 Tuusula Finland·Product code OAS·October 28, 2021

    L3 Security & Detection System Cabinet X-ray system used for security screening of checked airline baggage.

    FDA Recall
    Terminated ·Product code RCG·October 27, 2017

    Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)

    FDA Recall
    Open, Classified ·Philips Healthcare·Product code OWB·September 24, 2021

    Software versions Eos software versions: 1.2.4, 1.2.5, 1.2.6,1.2.7,1.2.8, 1.2.9,1.2.10, .2.11,1.2.12, 1.2.13, 1.3.2,1.3.3, 1.3.4, 1.4.0, 1.4.1, 1.4.2. sterEOS software versions: 1.2.3.3788, 1.2.4.4286, 1.3.2.3373, 1.3.3.3671, 1.3.4.3740, 1.3.5.3915, 1.3.6.4272,1.4.1.4813,1.4.2.4850. EOS system is a digital radiography system used in general radiographic examinations. sterEOS workstation is a medical image review station for acceptance, transfer, display, storage, and digital processing of 2D X-ray images.

    FDA Recall
    Terminated ·Eos Imaging 10, Rue Mercoeur Paris France·Product code LLZ·April 13, 2011

    Medtronic TSRH Spinal System, 3Dx Splined Connector, Large; Medtronic Sofamor Danek, Memphis, TN; REF 8351512. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions.

    FDA Recall
    Terminated ·Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK·Product code MNI·October 31, 2008

    Medtronic TSRH Spinal System, 3Dx Splined Connector, Small; Medtronic Sofamor Danek, Memphis, TN; REF 8351510. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions.

    FDA Recall
    Terminated ·Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK·Product code MNI·October 31, 2008

    Medtronic TSRH Spinal System, 3Dx Splined Connector, Medium; Medtronic Sofamor Danek, Memphis, TN; REF 8351511. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions.

    FDA Recall
    Terminated ·Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK·Product code MNI·October 31, 2008

    Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301A/2D X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of 0.35 s per rotation. The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, high-quality images, selectable image slice thickness, dual-monitor system, improved image diagnosis functions, high-speed volume data workflow, exposure reduction, ECG-gated scan and reconstruction, and SUREFluoro.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·November 5, 2014

    Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush wire to expose the brush, scraping the desired surface, and releasing the compression on the spring which retracts the brush back into the sheath. A protector tip on the end of the brush prevent contamination of the sample during the endoscopy procedure. The force required to dislodge the tip from the bristle is greater than to break the brush wire at the handle body.

    FDA Recall
    Open, Classified ·Hobbs Medical, Inc.·Product code FDX·December 28, 2021

    Lysus Transport Stand (infusion stand), part number 4896-003

    FDA Recall
    Terminated ·Ekos Corp·Product code FDX·October 12, 2006

    Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible endoscope when brush cell samples are required for cytological analysis.

    FDA Recall
    Terminated ·Hobbs Medical, Inc.·Product code FDX·May 1, 2018

    Hobbs Medical Cytology Brush Catalog Number: 4204

    FDA Recall
    Open, Classified ·Hobbs Medical, Inc.·Product code FDX·July 29, 2022

    Hobbs Medical Cytology Brush Catalog Number: 4206

    FDA Recall
    Open, Classified ·Hobbs Medical, Inc.·Product code FDX·July 29, 2022