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    Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 6, 2016

    iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IYE·June 19, 2019

    PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006

    FDA Recall
    Terminated ·3-D Matrix, Inc.·Product code NHB·December 2, 2019

    GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. GalaSHAPE" 3D is also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

    FDA Recall
    Terminated ·Tepha Incorporated·Product code OOD·November 21, 2016

    Vital Images ViTALConnect , Version 4.0 and 4.1, PET/CT Visualization option. Vital Images, Inc., 5850 Opus Parkway, Suite 300, Minnetonka, MN 55343. ( A web-based medical diagnostic tool that allows physicians to use PCs or notebook computers to gain remote access to 2D, 3D, and 4D advanced visualization. The software enables users to measure, rotate, and analyze images)

    FDA Recall
    Terminated ·Vital Images, Inc.·Product code LLZ·November 8, 2007

    BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic data management system, bioMerieux, Inc., P. O. Box 15969, Durham, NC 27704-0969 USA

    FDA Recall
    Terminated ·bioMerieux, Inc.·Product code MDB·December 19, 2006

    Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-ann Imaging System is compatible with certain Image Guided Surgery Systems.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code OXO·July 25, 2013

    Leonardo Workstation Picture Archiving and Communication System, Model Number: 7129534, Software Version: VB30B, Siemens Medical Solutions, Inc., Malvern, PA 19355

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LLZ·December 21, 2007

    MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, HydroSoft 3D, Sterile, Rx, REF numbers 100102HFRM-V, 100152HFRM-V, 100153HFRM-V, 100154HFRM-V, 100202HFRM-V, 100206HFRM-V, 100208HFRM-V, 100254HFRM-V, 100256HFRM-V, 100308HFRM-V, MV-00202HHTA, MV-00203HHTA, MV-00204HHTA, MV-00206HHTA, MV-00208HHTA, MV-00304HHTA, MV-00306HHTA, MV-00308HHTA, MV-00310HHTA, MV-00408HHTA, MV-00412HHTA, MV-00510HHTA, MV-00515HHTA, MV-00612HHTA, MV-00619HHTA, MV-00715HHTA, MV-00728HHTA, MV-00817HHTA, MV-00833HHTA, MV-01502HHTA, MV-01503HHTA, MV-01504HHTA, MV-02504HHTA, MV-02506HHTA, and MV-02508HHTA. Product Usage: The HES is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA.

    FDA Enforcement
    Class II ·Terminated·Microvention, Inc.·March 4, 2020

    ACUSON Antares 5.0 Base System, model number 10042832. Distributed by Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CA. The ACUSON Antares is a general purpose Diagnostic Ultrasound system. Its function is to acquire primary or secondary harmonic ultrasound 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, Harmonic Imaging, or 3D/4D imaging on a FPD display. The Antares ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures that provide information that is used for clinical diagnosis purposes.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYN·May 15, 2009

    ACUSON Sequoia 12.X GI Base System, model number 10042701. Distributed by Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CA. The ACUSON Sequoia is a general purpose Diagnostic Ultrasound system. 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, Harmonic Imaging or 3D imaging on a FPD Display. The ACUSON Sequoia is intended for the following applications: Abdominal, General Imaging and Cardiolgoy for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breat, testes, thyroid and penis), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Transesophageal, Transrectal, Transvaginal, Peripheral Vessels and Musculo-sceletal (superficial and conventional) applications. The system also provides for the measurement of anatomical structures that provide information that is used for clinical diagnosis purposes.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYN·May 15, 2009

    ACUSON Sequoia C512/512SS Adv PE 10.0 System, model number 10041127. Distributed by Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CA. The ACUSON Sequoia is a general purpose Diagnostic Ultrasound system. 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, Harmonic Imaging or 3D imaging on a FPD Display. The ACUSON Sequoia is intended for the following applications: Abdominal, General Imaging and Cardiolgoy for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breat, testes, thyroid and penis), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Transesophageal, Transrectal, Transvaginal, Peripheral Vessels and Musculo-sceletal (superficial and conventional) applications. The system also provides for the measurement of anatomical structures that provide information that is used for clinical diagnosis purposes.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYN·May 15, 2009

    ACUSON Sequoia 12.X C512/512 SS Base System, model number 10042700. Distributed by Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CA. The ACUSON Sequoia is a general purpose Diagnostic Ultrasound system. 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, Harmonic Imaging or 3D imaging on a FPD Display. The ACUSON Sequoia is intended for the following applications: Abdominal, General Imaging and Cardiolgoy for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breat, testes, thyroid and penis), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Transesophageal, Transrectal, Transvaginal, Peripheral Vessels and Musculo-sceletal (superficial and conventional) applications. The system also provides for the measurement of anatomical structures that provide information that is used for clinical diagnosis purposes.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYN·May 15, 2009

    MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft 3D, Sterile, Rx, REF numbers 100102HS3D-V, 100103HS3D-V, 100152HS3D-V, 100153HS3D-V, 100154HS3D-V, 100202HS3D-V, 100203HS3D-V, 100204HS3D-V, 100206HS3D-V, 100208HS3D-V, 100254HS3D-V, 100256HS3D-V, 100304HS3D-V, 100306HS3D-V, 100310HS3D-V, 100355HS3D-V, 100358HS3D-V, 100406HS3D-V, 100408HS3D-V, 100412HS3D-V, 100415HS3D-V, 100510HS3D-V, 100515HS3D-V; MV-00102HTDA, MV-00103HTDA, MV-00204HTDA,MV-00304HTDA, MV-00306HTDA, MV-00406HTDA, MV-00408HTDA, MV-00510HTDA, MV-01502HTDA, MV-01503HTDA, MV-01504HTDA; MV-02504HTDA, MV-02506HTDA, MV-03505HTDA, and MV-03508HTDA. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA.

    FDA Enforcement
    Class II ·Terminated·Microvention, Inc.·March 4, 2020

    Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·March 11, 2016

    Siemens brand ACUSON S2000, Model 10434730, ABVS ultrasound systems; Affected sub-components Numbers: (1) 10434968, Boom Welding (for S/Ns 250157, 250162, 250163, 250164, 250166, 250167 and 250169); (2) 10434969, Arm Welding (for S/N's 250171, 250173, 250177); Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Concord, CA The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging the breast allows volumetric acquisition of the breast image. It provides the operator with the option of using a controlled user independent automated scan motion. The resulting 3D display information enables comprehensive image review by the medical professional. In particular, the coronal plane is scanned, which is not easily accessible with hand-held ultrasound transducers.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYN·March 28, 2011

    Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·July 13, 2009

    Fungitell STAT- IVD Assay for (1 3)-~-D-Glucan in Serum Ref: FT007

    FDA Recall
    Terminated ·Associates of Cape Cod, Inc.·Product code NQZ·August 17, 2022

    MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, HydroSoft 3D, Sterile, Rx, REF numbers 100102HFRM-V, 100152HFRM-V, 100153HFRM-V, 100154HFRM-V, 100202HFRM-V, 100206HFRM-V, 100208HFRM-V, 100254HFRM-V, 100256HFRM-V, 100308HFRM-V, MV-00202HHTA, MV-00203HHTA, MV-00204HHTA, MV-00206HHTA, MV-00208HHTA, MV-00304HHTA, MV-00306HHTA, MV-00308HHTA, MV-00310HHTA, MV-00408HHTA, MV-00412HHTA, MV-00510HHTA, MV-00515HHTA, MV-00612HHTA, MV-00619HHTA, MV-00715HHTA, MV-00728HHTA, MV-00817HHTA, MV-00833HHTA, MV-01502HHTA, MV-01503HHTA, MV-01504HHTA, MV-02504HHTA, MV-02506HHTA, and MV-02508HHTA. Product Usage: The HES is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA.

    FDA Recall
    Terminated ·Microvention, Inc.·Product code HCG·November 22, 2019

    On-Board Imager (OBI) 1.3, 1.4, 1.5; and Trilogy Mx, TrueBeam 1.0, Offline Review 1.0 - 2.0; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields relation to anatomical and/or fiducial landmarks. Trilogy Mx is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·June 21, 2011