BEUDAMED
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    STENT

    FDA Adverse Event
    Injury ·CARDIOVASCULAR IMAGING SYSTEMS, INC.·Product code MAF·April 3, 1995

    CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM

    FDA Adverse Event
    Injury ·STERILMED, INC.·Product code OWQ·April 8, 2024

    SUREFORM

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code GDW·October 25, 2021

    DAVINCI

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code NAY·June 22, 2022

    ENDOWRIST

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code NAY·September 12, 2022

    ION

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code EOQ·October 28, 2022

    CSI, 4G 300-014

    FDA Adverse Event
    Malfunction ·BRIVANT LTD. T/A LAKE REGION MEDICAL RESEARCH CE·Product code DQX·June 8, 2018

    DAVINCI X

    FDA Adverse Event
    Death ·INTUITIVE SURGICAL, INC·Product code NAY·November 22, 2020

    IMPELLA

    FDA Adverse Event
    Death ·ABIOMED, INC. - 1220648·Product code OZD·May 14, 2026

    ION

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code EOQ·June 6, 2023

    LUTONIX 018 DRUG COATED BALLOON PTA CATHETER

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (GFO)·Product code ONU·May 16, 2019

    ION

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code EOQ·October 9, 2024

    DA VINCI

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code NAY·June 23, 2022

    ION

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code EOQ·September 8, 2022

    The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only attenuation correction and anatomical localization. The Symbia Intevo Series are xSPECT systems. These are SPECT and T systems integrated through xSPECT technology during image registration and reconstruction. This xSPECT integration enables the use of extra-modal information for high image quality and quantification. The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 5S8keV. CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. SPECT+CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy. Software: The MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, PET, CT and other imaging modalities.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·January 14, 2015

    ADVANTA VXT, GDS

    FDA Adverse Event
    Injury ·ATRIUM MEDICAL CORP.·Product code DSY·January 2, 2013

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code DTK·October 6, 2017

    PREFACE

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code DYB·May 14, 2026

    GE Healthcare Innova 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular imaging system). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy of cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.

    FDA Recall
    Terminated ·Datex Ohmeda, Inc·Product code MQB·August 17, 2006

    ACUSON X300, X300 PE and SONOVISTA X300 (all versions) with cardiovascular options installed; ACUSON X300: 10037409, 10132987, 10038837; SONOVISTA X300: 10133170; ACUSON X300 PE: 10348531, 10348532, 10348533; X300 Cardiovascular Options: 10133037, 10348777, 10349032, 10427797, 10427822, 10427816, 10563788; Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CA The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/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.

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