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    IMRIS ORT100 Table, Part Number 110470-000

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·March 21, 2018

    IMRIS T2X Table, Part Number 109682-600

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·March 21, 2018

    Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: The Allura Xper FD10 and Alllura Xper FD10/10 is intendd for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). The Allura Xper FD20, Allura Xper FD20/10, Allura Xper FD20/15 and Allura Xper FD10/10 is intended for: Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and ElectroPhysiology. Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Additionally: The Allura Xper FD series is compatible with a hybrid Operating Room (OR Table)

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·March 7, 2018

    IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·April 4, 2018

    IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·April 4, 2018

    IMRIS T2X Table, Part Numbers: (a) 108000-000 (b) 108000-600 (c) 109682-000 (d) 109682-600

    FDA Recall
    Terminated ·Deerfield Imaging, Inc.·Product code FQO·February 23, 2018

    IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b) 113821-600 (c) 114148-000 (d) 114148-600

    FDA Recall
    Terminated ·Deerfield Imaging, Inc.·Product code FQO·February 23, 2018

    IMRIS T2X Table, Part Number 109682-600

    FDA Recall
    Terminated ·Deerfield Imaging, Inc.·Product code FQO·February 20, 2018

    IMRIS ORT100 Table, Part Numbers: (a) 110470-000 (b) 110470-600

    FDA Recall
    Terminated ·Deerfield Imaging, Inc.·Product code FQO·February 23, 2018

    IMRIS ORT100 Table, Part Number 110470-000

    FDA Recall
    Terminated ·Deerfield Imaging, Inc.·Product code KXJ·February 20, 2018

    IMRIS ORT300, Removable Operating Room Table, Part Numbers: (a) 114093-000 (b) 114093-600

    FDA Recall
    Terminated ·Deerfield Imaging, Inc.·Product code FQO·February 23, 2018

    IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000, (b) 114093-006 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient.

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·December 26, 2018

    IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient.

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·December 26, 2018

    IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 114148-000, (d) 114148-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient.

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·December 26, 2018

    SoftLase Pro Dental Lasers: Zap SoftLase, SoftLase Pro, OrthoLase, and HygieneLase models, Model numbers ZA-SLP, ZA-ORT, ZA-HYG, G22002SLP, ZA-SOFTLASE2WSII, ZA-SOFTLASER2W, Manufactured by Zap Lasers LLC, Pleasant Hill, CA. Intended use: Dentistry.

    FDA Recall
    Terminated ·Zap Lasers LLC·Product code NVK·August 8, 2008

    IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000, (b) 114093-006 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient.

    FDA Recall
    Terminated ·Deerfield Imaging, Inc.·Product code FQO·November 6, 2018

    IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient.

    FDA Recall
    Terminated ·Deerfield Imaging, Inc.·Product code FQO·November 6, 2018

    IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 114148-000, (d) 114148-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient.

    FDA Recall
    Terminated ·Deerfield Imaging, Inc.·Product code FQO·November 6, 2018

    Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Siemens Medical Solutions USA, Inc., Hoffman Estates, IL 60195-2061 Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code KPS·April 22, 2009

    Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System; Siemens Medical Solutions USA, Inc., Hoffman Estates, IL 60195-2061 Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code KPS·April 22, 2009