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    Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A

    FDA Recall
    Open, Classified ·Hitachi America, Ltd., Particle Therapy Division·Product code LHN·May 27, 2024

    The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling surgical light systems typically include one or more arms that are able to rotate 360 degrees around a central axis.

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FSY·May 29, 2015

    INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is registered as lnfinix CF-i or lnfinix VF-i, for national regulations. INFX-8000V series includes a floor mounted multi-axis positioner.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code OWB·March 11, 2015

    Abbott Spine PathFinder, Cannulated Poly Screwdriver II - MOD, non-sterile, Manufactured by Abbott Spine, Inc., Austin, TX; Ref. 1160-2. Usage: The screwdriver is intended to mate to the hexalobular feature of a PathFinder open polyaxial screw and threads onto the head to hold it in on-axis for implanting.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code MNI·January 12, 2009

    Aquilion 32 CT System; Model number TSX-101 A/K The product is an x-ray device that uses digital geometry to generate a three-dimensional image of the inside of an object from a large series of two-dimensional X-ray images take around a single axis of rotation

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·January 8, 2009

    Aquilion 32 CT System; Model number TSX-101 A/I The product is an x-ray device that uses digital geometry to generate a three-dimensional image of the inside of an object from a large series of two-dimensional X-ray images take around a single axis of rotation

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·January 8, 2009

    Aquilion 64 CT System; Model number TSX-101 A/J The product is an x-ray device that uses digital geometry to generate a three-dimensional image of the inside of an object from a large series of two-dimensional X-ray images take around a single axis of rotation

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·January 8, 2009

    Aquilion 64 CT System; Model number TSX-101 A/D The product is an x-ray device that uses digital geometry to generate a three-dimensional image of the inside of an object from a large series of two-dimensional X-ray images take around a single axis of rotation

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·January 8, 2009

    Aquilion 32 CT System; Model number TSX-101 A/E The product is an x-ray device that uses digital geometry to generate a three-dimensional image of the inside of an object from a large series of two-dimensional X-ray images take around a single axis of rotation.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·January 8, 2009

    Drystar AXYS, Hardcopy Printer A free standing device used to print diagnostic conventional and mammography images on transparent film for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable.

    FDA Recall
    Terminated ·AGFA Corp.·Product code LMC·May 16, 2008

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Recall
    Terminated ·Carl Zeiss Meditec AG Carl Zeiss Promenade 10 Jena Germany·Product code HJO·October 27, 2015

    Aquilion 64 CT System; Model number TSX-101 A/H The product is an x-ray device that uses digital geometry to generate a three-dimensional image of the inside of an object from a large series of two-dimensional X-ray images take around a single axis of rotation

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·January 8, 2009

    OPMI VARIO 700 Surgical Microscope. Manufactured by: Carl Zeiss Meditec AG, Oberkochen, Germany. Provide a magnified view of the surgical field.

    FDA Recall
    Terminated ·Carl Zeiss Meditec, Inc.·Product code EPT·September 26, 2011

    Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, REF: 380652, with instrument arms, used as part of the da Vinci Xi Surgical System, REF: IS4000

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code NAY·January 24, 2023

    da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code NAY·February 10, 2023

    Focus DAILIES Toric (nelfilcon), One-Day Contact Lenses, Daily Disposable (hydrophilic) soft contact lens, Rx only, Sterile, -1.50, -1.75 x 090, BC 8.6, DIA 14.2, CIBA Vision Corp., Duluth, GA 30097. USA. The product is packaged and distributed as 15 and 30 packs.

    FDA Recall
    Terminated ·Ciba Vision Corporation·Product code LPL·May 6, 2003

    MX60ET (enhanced enVista Toric) enVista One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placement in the capsular bag.

    FDA Recall
    Terminated ·Bausch & Lomb Surgical, Inc.·Product code MJP·November 7, 2020

    Sedecal NOVA FA DR System. for diagnostic radiography.

    FDA Recall
    Open, Classified ·Sedecal S.A. Pol. Industrial Rio De Janiero Calle Pelaya 9-13 Algete Spain·Product code MQB·July 18, 2018

    DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft

    FDA Recall
    Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code HWC·May 12, 2017

    DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft

    FDA Recall
    Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code HWC·May 12, 2017