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    Widefield OCT software feature for the Spectralis HRA+OCT and variants

    FDA Recall
    Terminated ·Heidelberg Engineering·Product code OBO·December 8, 2017

    The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a non- contact, high resolution, wide field of view tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dimensional imaging of posterior ocular structures. The device is indicated for visualizing posterior ocular structures including, but not limited to, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, optic nerve head, vitreous and choroid. The PLEX Elite SS-OCT angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.

    FDA Recall
    Terminated ·Carl Zeiss Meditec, Inc.·Product code OBO·October 16, 2018

    Cirrus HD-OCT Model 400 instruments; new and refurbished, with or upgraded to, version 4.6 or 5.1.0 software. The Cirrus HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device.

    FDA Recall
    Terminated ·Carl Zeiss Meditec Inc·Product code OBO·March 10, 2011

    Cirrus HD-OCT Model 4000 instruments, new and refurbished, distributed with, or upgraded to, version v 1.0 - 4.5, 5.0.0 or 5.1.0 The Cirrus HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device.

    FDA Recall
    Terminated ·Carl Zeiss Meditec Inc·Product code OBO·March 10, 2011

    Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).

    FDA Recall
    Terminated ·Zimmer Spine, Inc.·Product code KWP·February 3, 2016

    Stratus OCT Model 3000 instruments distributed with version 6.0.0 software, product number 2660021119710 (new instrument) or 2660022119710 (refurbished instrument), and Stratus 6.0.0 Software Kit, product number 2660021133164. The Stratus OCT is a high resolution tomographic device for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging and measurement of the retina, retinal nerve fiber layer, macula, and optic disk. The Stratus OCT with Retinal Nerve Fiber Layer and Macula Normative Database is a quantitative tool for the comparison of retinal nerve fiber layer in the human retina to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases, including, but not limited to, macular edema, central serous retinopathy, and glaucoma.

    FDA Recall
    Terminated ·Carl Zeiss Meditec Inc·Product code HLI·July 31, 2009

    Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT Systems when intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (Occiput-T3), these systems are indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; atlantoaxial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors. The occipital bone screws are limited to occipital fixation only

    FDA Recall
    Terminated ·Zimmer Biomet Spine, Inc·Product code MAX·March 16, 2017

    RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver

    FDA Recall
    Terminated ·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code KWP·March 18, 2016

    Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.

    FDA Recall
    Terminated ·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code KWP·April 22, 2016

    Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw

    FDA Recall
    Terminated ·ulrich medical USA Inc·Product code KWP·December 31, 2019

    RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L) Product Usage: When intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic System is intended for: degenerative disc disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/ dislocation, atlanto/axial fracture with instability, occipito-cervical dislocation, deformities or curvature, tumors, pseudoarthrosis, and revision of previous cervical and upper thoracic spine surgery. The occipital bone screws are limited to occipital fixation only. The use of the pedicle screws (standard and high angle) is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The pedicle screws are not intended for use in the cervical spine. The hooks, connectors, and rods are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.

    FDA Recall
    Terminated ·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code KWP·September 16, 2016

    Imalux Niris OCT Imaging System Probe, Model Number 1300, Serial Number F464019, IMALUX Corporation, Cleveland, OH The Niris Imaging System probe is used with the Niris Imaging System. The Niris Imaging System employs Optical Coherence Tomography (OCT), which can be used to construct high spatial resolution. The probe, is attached to the Imaging Console, and is used to direct light to and from the patient tissue. A small electromechanical scanning mechanism in the probe moves the optical beam laterally across the tissue surface while simultaneously acquiring in-depth backscattering profile at each lateral position. The probe is not labeled or sold as sterile.

    FDA Recall
    Terminated ·Imalux Corporation·Product code NQQ·December 22, 2011

    St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3650

    FDA Recall
    Terminated ·St Jude Medical CRMD·Product code KRG·October 6, 2006

    St. Jude Medical APS III Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3500/3510

    FDA Recall
    Terminated ·St Jude Medical CRMD·Product code KRG·October 6, 2006

    St. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR Model 5376; Pulse Generators (pacemakers)

    FDA Recall
    Terminated ·St Jude Medical CRMD·Product code DXY·October 6, 2006

    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Recall
    Terminated ·Optovue Inc.·Product code OBO·September 7, 2012

    Centrifuge Model CF-6 with lid lock. (Block Model number OCT-VI). Units are distributed to Bloch Scientific, Holbrook, NY for Bloch''s customers MFT and Cascade.

    FDA Recall
    Terminated ·Cygnus LLC·Product code JQC·February 4, 2005

    Centrifuge Model CF-6 with lid lock. (Block Model Number OCT-VI). Units are distributed to Bloch Scientific, Holbrook, NY for Bloch''s customers MFT and Cascade.

    FDA Recall
    Terminated ·Cygnus LLC·Product code JQC·September 8, 2005

    Microtainer Brand Tube with EDTA (K2), Catalog Number 365974.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code JKA·October 16, 2002

    ICON 25 hCG Test Kit

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code JHI·October 31, 2003