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    Siemens brand ACUSON S2000 Ultrasound Systems, and the Advanced SieClearTM spatial compounding feature Software Versions 3.0, 3.0A and 3.1. (VB20, VB20A, and VB21A); Model #: 10041461 - ACUSON S2000 Mainframe; Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Mountain View, CA The ACUSON S2000 Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display. The ACUSON S2000 ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYO·April 23, 2012

    10041461 ACUSON S2000, manufactured by Siemens Medical Solutions, Mountain View, CA. Intended for Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/Gyn, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYO·October 2, 2009

    Siemens ACUSON X300 Premium Edition Systems with software versions 5.0.00 and 5.0.01 (model numbers 10348531, 10348532 and 10348533), when using the V5Ms transducer (model number 08263703) and the Plus option (10427795) Product is an ultrasound imaging system intended for General Radiology,Fetal, Abdominal, Intaoperatve, Pediatric, Small parts, Neunatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and peripheral Vascular Applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. The Arterial Health Package software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published with peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding the state of their cardiovascular system. The V5Ms is a multifrequency,multi-plane, phased sector array transducer, which can be introduced into the esophagus to obtain heart structure images. Transesophageal echocardiography is used to obtain unobstructed views of the heart surrounding tissue.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYO·July 24, 2009

    CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX instrument navigator and (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex sensor covers (5), Ref. 5350925. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices

    FDA Recall
    Terminated ·Civco Medical Instruments Inc·Product code IYO·May 7, 2012

    CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX Instrument navigator and (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex sensor covers (5), Ref. 610-1080. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices

    FDA Recall
    Terminated ·Civco Medical Instruments Inc·Product code IYO·May 7, 2012

    Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature

    FDA Recall
    Terminated ·Volcano Corporation·Product code IYO·June 22, 2015

    Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5ix/s5iz Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature

    FDA Recall
    Terminated ·Volcano Corporation·Product code IYO·June 22, 2015

    VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX

    FDA Recall
    Terminated ·Civco Medical Instruments Co. Inc.·Product code IYO·October 8, 2021

    GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and DICOM stations with these software versions; GE Healthcare 9900 West Innovation Drive, Wauwatosa, WI 53226, USA.

    FDA Recall
    Terminated ·Ge Healthcare·Product code IYO·July 6, 2007

    NEMIO Ultrasound System, Model SSA-550A , Software versions: V3.1.000B, V3.5.0, V3.5.000A, V3.5.000B, V3.6.0, V3.6.000A, V4.0.0, V4.0.000A, V4.l.0, V4.l.000A, V4.2.0, V4.3.0, V4.5.0, V4.5.000A, Toshiba America Medical Systems, Inc., Tustin, CA.

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code IYO·August 29, 2007

    Boston Scientific iLab Ultrasound Imaging System, models 120INS and 240INS. Its intended use is for ultrasound examination of intravascular pathology. Manufactured by Boston Scientific Corporation, Fremont, CA.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code IYO·September 5, 2008

    AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements

    FDA Recall
    Terminated ·Verathon, Inc.·Product code IYO·August 23, 2010

    CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 610-1066. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices

    FDA Recall
    Terminated ·Civco Medical Instruments Inc·Product code IYO·May 7, 2012

    Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5i -806300-020 ; s5ix/s5iz - 807400-001; CORE - 400-0 I 00.02. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.

    FDA Recall
    Terminated ·Volcano Corp·Product code IYO·September 23, 2013

    Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human body. Site~Rite 8 Ultrasound System, Catalog No.9770500 Refurbished, Site~Rite 8 System, Catalog No.9770500R Site~Rite 8 Ultrasound System, Catalog No.9770501 Refurbished Site~Rite 8 System,Catalog No.9770501R Site~Rite 8 Ultrasound System, Catalog No. 9770550 Site~Rite 8 Ultrasound System, Catalog No. 9770552 Site~Rite 8 Ultrasound System, Catalog No. 9770553 Site~Rite 8 Ultrasound System, Catalog No. 9770554 Site~Rite 8 Ultrasound System, Catalog No. 9770555 Site~Rite 8 Ultrasound System Console with Connector, Catalog No.: 9770600 Site~Rite 8 Ultrasound System Console with Connector, Refurbished, Catalog No: 9770600X Site~Rite 8 Ultrasound System Console with Connector (Remanufactured) Catalog No: 9770600Y

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code IYO·November 4, 2019

    VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX

    FDA Recall
    Terminated ·Civco Medical Instruments Co. Inc.·Product code IYO·October 8, 2021

    ACUSON S2000 ultrasound systems (all versions) with cardiovascular options installed; ACUSON S2000: 10041461; S2000 Cardio Option: 10041853; Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CA The ACUSON S2000 Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display. The ACUSON S2000 ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc., Mountain View, CA 1230 Shorebird Way P.O. Box 7393 Mountain View CA 94043·Product code IYO·August 17, 2010

    Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and distributed by Volcano Corporation, Rancho Cordova, CA. Medical device for use in imaging of histology.

    FDA Recall
    Terminated ·Volcano Corporation·Product code IYO·August 24, 2012

    ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are #10434968 - Boom Welding and 10434969 - Arm Welding. The S2000 ABVS ultrasound System for imaging the breast allows volumetric acquisition of the breast image.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYO·January 12, 2015

    iLab Ultrasound Imaging System, Models 120INS and 240INS, manufactured by Boston Scientific Corporation, Fremont, CA 94538

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code IYO·April 11, 2000