BEUDAMED
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    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 Enforcement
    Class II ·Terminated·EOS Imaging·January 1, 2014

    Villa Sistemi Rotograph EVO 3D X-ray

    FDA Enforcement
    Class II ·Terminated·Villa Radiology Systems LLC·November 18, 2015

    Owandy Radiology I -MAX Touch 3D X-ray

    FDA Enforcement
    Class II ·Terminated·Villa Radiology Systems LLC·November 18, 2015

    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

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

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·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

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

    FDA Enforcement
    Class II ·Terminated·L3 Security & Detection·January 3, 2018

    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

    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 Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·December 3, 2014

    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

    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

    ROSA One 3.1 Brain Application

    FDA Recall
    Terminated ·MEDTECH SAS 900 Rue Du Mas De Verchant Montpellier France·Product code HAW·January 6, 2020

    ROSA Brain 3.0 Application-Brain

    FDA Recall
    Terminated ·MEDTECH SAS 900 Rue Du Mas De Verchant Montpellier France·Product code HAW·January 6, 2020

    Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0615, Size #15, General Surgical Use, Sterile, unless package is damaged or opened., Southmedic Inc., 50 Alliance Blvd., Barrie, ON., Canada L4M 5K3 www.southmedic.com, Made in Canada.

    FDA Recall
    Terminated ·Southmedic, Inc. 50 Alliance Blvd. Barrie Canada Ontario·Product code GDX·September 3, 2010