BEUDAMED
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    Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM ServicePack 1 and EZU-FC5W.

    FDA Recall
    Terminated ·Hitachi Medical Systems America Inc·Product code ITX·May 7, 2004

    EUB-9500/HI VISION 8500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC6, Software Versions: V11-01, V11-03, V12-03 and V12-04A.

    FDA Recall
    Terminated ·Hitachi Medical Systems America Inc·Product code ITX·May 12, 2008

    EUB-6500/HI VISION 6500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC5, Software Versions: V01-03, V01-05, V02-04, V03-02, V04-02, V04-03, V04-04, V05-03, V05-05A, V05-07A and V05-30A.

    FDA Recall
    Terminated ·Hitachi Medical Systems America Inc·Product code ITX·May 12, 2008

    Leksell Gamma Knife C

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·August 1, 2006

    Leksell Gamma Knife Perfexion, Radionuclide radiation therapy system. Article Number 715000, Elekta, Inc. Norcross, GA 30092. Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sized os a few millimeters to several centimeters.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·November 9, 2008

    Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, basic measurements and 3D visualization (reconstructions and volume rendering). Features for navigation planning include multi-modality image fusion as well as object and trajectory creation. It is not intended for primary image diagnosis or the review of mammographic images.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·November 11, 2015

    Leksell Gamma Knife C

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·September 1, 2006

    2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device designed for use with the CVX-300" Excimer Laser System. The Turbo-Power Laser Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral atherectomy. Turbo-Power is used exclusively with SPNC s CVX 300" Excimer Laser System and is a Type CF device, Defibrillation proof. Turbo-Power is a laser atherectomy catheter designed for treatment of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA). Turbo-Power is used to directionally ablate infrainguinal concentric and eccentric lesions in vessels that are 3.5 mm or greater in diameter. The device is comprised of three parts: the working length of the catheter shaft (also the applied part), the motor drive unit (MDU), and the proximal laser shaft which connects the catheter fiber optics to the CVX-300" Excimer Laser System.

    FDA Enforcement
    Class II ·Terminated·Spectranetics Corp.·February 17, 2016

    PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER Cryptococcal Antigen enzyme immunoassay (EIA) is a screening or a semi-quantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and cerebrosoinal fluid (CSF).

    FDA Recall
    Terminated ·Meridian Bioscience Inc·Product code MDU·December 17, 2018

    VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn Plugs. Model number 1813, 1814, 1815, 1903, 1904, and 1905. This device is cylindrical in shape, approximately 1.75-2.00mm in length, and available in three sizes: 0.3mm, 0.4mm and 0.5mm. Plugs are place in the upper and/or lower horizontal canaliculus. Two plugs are placed into a foam carrier and nitrogen sealed inside a foil pouch. The foil pouch is sent to sterilizer for gamma sterilization. Two sterile pouches are packaged in a box with an IFU.

    FDA Recall
    Terminated ·Lacrimedics Inc·Product code LZU·November 26, 2014

    OASIS Medical SOFT PLUG Extended Duration Plug, Reference 6403 (Lot LA1105E)

    FDA Recall
    Terminated ·Oasis Medical Inc·Product code LZU·July 6, 2006

    TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB).

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·October 9, 2019

    2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device designed for use with the CVX-300" Excimer Laser System. The Turbo-Power Laser Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral atherectomy. Turbo-Power is used exclusively with SPNC s CVX 300" Excimer Laser System and is a Type CF device, Defibrillation proof. Turbo-Power is a laser atherectomy catheter designed for treatment of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA). Turbo-Power is used to directionally ablate infrainguinal concentric and eccentric lesions in vessels that are 3.5 mm or greater in diameter. The device is comprised of three parts: the working length of the catheter shaft (also the applied part), the motor drive unit (MDU), and the proximal laser shaft which connects the catheter fiber optics to the CVX-300" Excimer Laser System.

    FDA Recall
    Terminated ·Spectranetics Corp.·Product code MCW·January 15, 2016

    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

    Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301C 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. The CT cardiac function analysis software is used to analyze cardiac function using data obtained by performing cardiac MPR processing for ECG-gated scan data according to the cardiac axis. Aquilion ONE is a dynamic volume CT system that supports whole-body scanning. This 320-detector row system generates 640 slices per rotation using the coneXact reconstruction algorithm. In addition, the high-speed rotation mechanism and the fast reconstruction unit of the system allow the rapid image acquisition to further improve throughput in CT examinations.

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

    The product is a mobile 3-wheeled electric scooter, model HMV 250. The product contains either a red or blue base. The red base is identified with SKU #915363224. The blue base is identified with SKU #915363225. The product is distributed by the Invacare Corporation.

    FDA Recall
    Terminated ·Tung Keng Enterprise Co., Ltd. No.1, Lane 160, Section 2, Tan-Fu Road Tai-Tzu Hsiang, Taichung County Taiwan·Product code INI·November 1, 2005

    The product is a mobile 3-wheeled electric scooter, model HMV 220. The product contains either a red or blue base. The red base is identified with SKU #9153641905. The blue base is identified with SKU #9153641906. The product is distributed by the Invacare Corporation.

    FDA Recall
    Terminated ·Tung Keng Enterprise Co., Ltd. No.1, Lane 160, Section 2, Tan-Fu Road Tai-Tzu Hsiang, Taichung County Taiwan·Product code INI·November 1, 2005