12 results
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41ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA Inc. business Unit: Ultrasound. The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging of the breast allows volumetric acquisition of the breast image.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·March 20, 2013
Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
FDA Enforcement
Class II
·Terminated·Sensus Healthcare, Inc.·March 15, 2023
Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
FDA Recall
Terminated
·Sensus Healthcare, Inc.·Product code JAD·February 10, 2023
Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc; Pleasanton, CA. General ophthalmic imaging including retinal, corneal and external imaging. Photo-documentation of pediatric ocular diseases including retinopathy of prematurity. Screening for Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP.
FDA Enforcement
Class II
·Terminated·Clarity Medical Systems Inc·March 26, 2014
TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography The TVC Imaging System is an intravascular imaging device that simultaneously assesses vessel composition and structure using near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS). This dual-modality instrument performs near-infrared spectroscopic analysis of the vessel to detect lipid core-containing plaques of interest (LCP) displayed in a map called a Chemogram, and simultaneously generates high resolution IVUS images that display structural details of the vessel and plaque in transverse and longitudinal views
FDA Recall
Terminated
·Infraredx, Inc.·Product code OGZ·December 15, 2016
Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc; Pleasanton, CA. General ophthalmic imaging including retinal, corneal and external imaging. Photo-documentation of pediatric ocular diseases including retinopathy of prematurity. Screening for Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP.
FDA Recall
Terminated
·Clarity Medical Systems Inc·Product code HKI·March 7, 2014
Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View, CA 94043 Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that provide information to the clinician for clinical diagnosis purposes.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·July 10, 2013
Optovue iVue optical coherence tomography system, computer controlled opthalmic imaging system, manufactured by Optovue, Fremont, CA Computer controlled opthalmic imaging system. Device scans the patient's eye using low coherence interferometer to measure the reflectivity of the retinal tissue. The cross sectional retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface. The computer has a graphic user interface for acquiring and analyzing the image. The iVue offers three scans: Retina, Glaucoma and Cornea. For the cornea scan, a lens must be attached to the front of the device for proper scanning. This is the Cornea Anterior Module (CAM).
FDA Recall
Terminated
·Optovue Inc.·Product code NQQ·July 20, 2010
ACUSON SC2000 Ultrasound System; Power Input: 100-240VAC, 1600W Max, 50/60 Hz. Manufacturer: Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 SC2000 ultrasound imaging system is intended for Cardiac, neo-natal and fetal cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal interoperative, Intraoperative Neurological, Musculo-skeletal Conventional and musculo-skeletal Superficial Applications. The system also provided the ability to measure anatomical structures and calculation packages that provide information to the clinician that my be used adjunctively and with other medical data obtained by a physician for clinical diagnosis purposes.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·December 22, 2013
DirectFRAP (Direct Flourescence Recovery After Photobleaching) Imaging System is an extension unit for Axio Observer that is used for microscopic analyses of dynamic processes within living cells. The DirectFRAP module is a component used in conjunction with Laser Scanning Microscopes, Non-Medical Devices for Research Use. The DirectFRAP Imaging System is a Class 3B laser system. The DirectFRAP Imaging System is a laser manipulation slider which allows coupling of laser light simultaneously with the conventional fluorescence illumination into the reflected-light beam path of the microscope system. Depending on the application, the laser light is used for the targeted bleaching of fluorophores for FRAP experiments or for the conversion of fluorophores within the cell.
FDA Recall
Terminated
·Zeiss, Carl Inc·Product code REK·April 28, 2011
TomoTherapy HI-ART Systems with versions 2.2.4, 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Planned Adaptive, Data Management System, and TomoPortal. TomoTherapy HI-ART Systems is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT). The HI-ART System provides precise delivery of radiation to tumors or other targeted tissues while minimizing the delivery of radiation to vital health tissue. The HI-Art system's planning station or operator station is intended to be used by the physician/oncologists to prescribe a radiation therapy plan for a particular patient,. The HI-ART System then calculates the treatment plan which the physician reviews and approves. The HI-ART system's operator station and status console is then intended to be used by the therapist to select and implement the patient's treatment plan. The treatment process will begin by performing a TomoImage (MVCT) scan (a CT using the on board linear accelerator as the radiation source). This TomoImage (MVCT) will confirm that the patient's position is correct for the radiation therapy as well as assist in patient re-positioning when necessary. The TomoImage (MVCT) image is not for diagnostic use. When patient positioning is complete, the HI-ART System i sthen intended to be used by the therapist to treat the patient using the selected treatment plan. The HI-ART System delivers the radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment in accordance with the physician approved plan delivered in a helical tomographic pattern.
FDA Recall
Terminated
·TomoTherapy Incorporated·Product code IYE·October 14, 2008
ACUSON SC2000 Ultrasound System; Power Input: 100-240VAC, 1600W Max, 50/60 Hz. Manufacturer: Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 SC2000 ultrasound imaging system is intended for Cardiac, neo-natal and fetal cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal interoperative, Intraoperative Neurological, Musculo-skeletal Conventional and musculo-skeletal Superficial Applications. The system also provided the ability to measure anatomical structures and calculation packages that provide information to the clinician that my be used adjunctively and with other medical data obtained by a physician for clinical diagnosis purposes.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·February 5, 2014