158 results
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21ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Presage ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbent assay (ELISA) in a microtiter plate format. The Presage ST2 Assay is indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.
FDA Recall
Terminated
·Critical Diagnostics·Product code OYG·February 28, 2012
Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. Continuous temperature monitoring.
FDA Enforcement
Class II
·Terminated·Vital Signs Devices, a GE Healthcare Company·August 21, 2013
GE, 1011-9000-000 Aisys Anesthesia Machine and Monitor
FDA Recall
Terminated
·Ge Healthcare, Llc·Product code BSZ·March 12, 2010
GE, 1009-9002-000 Avance Anesthesia Machine and Monitor
FDA Recall
Terminated
·Ge Healthcare, Llc·Product code BSZ·March 12, 2010
GE Centricity PACS (Picture Archiving and Communication System) RA1000 Workstation software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS is used to receive, store, distribute, display, manipulate, edit and annotate images throughout a clinical environment.
FDA Recall
Terminated
·GE Healthcare Integrated IT Solutions·Product code LLZ·September 25, 2009
GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·April 24, 2013
GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations,injections or biopsy.
FDA Enforcement
Class II
·Terminated·GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD·October 30, 2013
SoftLase Pro Dental Lasers: Zap SoftLase, SoftLase Pro, OrthoLase, and HygieneLase models, Model numbers ZA-SLP, ZA-ORT, ZA-HYG, G22002SLP, ZA-SOFTLASE2WSII, ZA-SOFTLASER2W, Manufactured by Zap Lasers LLC, Pleasant Hill, CA. Intended use: Dentistry.
FDA Recall
Terminated
·Zap Lasers LLC·Product code NVK·August 8, 2008
GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code OWB·October 21, 2011
AMX Navigate Mobile X-Ray System
FDA Recall
Terminated
·GE Healthcare, LLC·Product code IZL·June 24, 2021
GE Signa Advantage nuclear magnetic resonance imaging system.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code LNH·August 19, 2005
GE Centricity PACS-IW software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. Device that receives, stores and communicates medical images and data from various imaging sources.
FDA Recall
Terminated
·Ge Healthcare It·Product code LLZ·February 11, 2010
GE Centricity Web Diagnostic (WebDX) software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. Device that receives, stores and communicates medical images and data from various imaging sources.
FDA Recall
Terminated
·Ge Healthcare It·Product code LLZ·February 11, 2010
PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for identification of beta-hemolytic streptococci of Lancefield Groups A, B, C, F or G from primary culture plates.
FDA Enforcement
Class II
·Terminated·Remel Inc·August 19, 2015
GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The devices are intended for volume or pressure control ventilation.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code BSZ·December 15, 2015
GE Centricity Laboratory Instrument Interface software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval.
FDA Recall
Terminated
·Ge Healthcare It·Product code JQP·August 27, 2010
GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations,injections or biopsy.
FDA Recall
Terminated
·GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD
No. 2 Yong Chang North Rd.
Beijing Econ. & Tech. Dev. Zone
Beijing China·Product code OXO·September 18, 2013
GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010
FDA Recall
Terminated
·GE Healthcare Integrated IT Solutions·Product code LLZ·January 12, 2007
GE Inspection Technologies Blade|line Industrial Cabinet X-ray system
FDA Recall
Terminated
·Product code RCE·June 28, 2017
GE Centricity Web Diagnostic 1.0(WebDX) software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Intended use:The Centricity PACS-IW is used to receive medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
FDA Recall
Terminated
·Ge Healthcare It·Product code LLZ·February 18, 2010