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    CANNULATED PLUS HIP SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GEMINI RAPTOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    LARGE AO COUPLING ASNIS III HALL FITTING

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·September 25, 2012

    ENDOTRACHEAL TUBE 7.5 MM EMG FLEX

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC.·Product code BTR·July 28, 2010

    MAINFRAME 8253001 NIM RESPONSE 3.0

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC·Product code ETN·December 16, 2013

    PINNACLE SECTOR II CUP 54MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code MRA·July 30, 2015

    PULSE-GENERATOR, PACEMAKER, EXTERNAL

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code DTE·February 9, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·January 3, 2011

    ENDOTRACH TUBE 8229306J NIM EMG 6MM

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC·Product code ETN·March 6, 2013

    ENDOTRACHEAL TUBE 8229307 NIM EMG 7MM RE

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC.·Product code ETN·May 10, 2013

    ENDOTRACH TUBE 8229980 5PK 8MM EMG FLEX

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC.·Product code ETN·March 11, 2013

    MAINFRAME 8253001 NIM RESPONSE 3.0

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code ETN·August 26, 2013

    ENDOTRACH TUBE 8229980 5PK 8MM EMG FLEX

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code ETN·February 11, 2013

    NIM® EMG - ENDOTRACHEAL TUBE - NIM FLEX¿

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code ETN·October 18, 2021

    MAINFRAME 8253001 NIM RESPONSE 3.0

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code ETN·August 28, 2013

    GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI TF, 16, 64, and 16 Base Slice configurations, Model Numbers: 4535 679 83931, 4535 679 94741, and 4535-674 41711, 510(k) #K052640

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·January 26, 2009

    Philips GEMINI TF 64 Diagnostic CT X-ray/PET Imaging System, Catalog/Model #882471, 510(k) #K052640. System units equipped with software version: 3.5.2 are subject to recall/field correction. The GEMINI TF I6, and TF 64 are diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·April 25, 2011

    Philips GEMINI TF 16 Diagnostic CT X-ray/PET Imaging System, 510(k) #K052640. System units equipped with software version: 3.5.2 are subject to recall/field correction. The GEMINI TF I6, and TF 64 are diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·April 25, 2011

    Philips GEMINI TF64 Diagnostic Imaging Systems, Model Number: 882471, 510(k) #K052640, Serial Numbers: 7502, 7504, 7506, 7514, 7083 and 7164. The recalled GEMINI TF64 system units equipped with software versions: 3.5.1.1 and 3.5.2.1 are subject to recall/software correction. The GEMINI TFI6, TF64 and TF Big Bore (BB) are all diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·May 31, 2011