61 results
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94ms
·
Sources: EU EUDAMED, US FDA
CENTRICITY TRIWIN LABORATORY INFORMATION SYSTEM
FDA Adverse Event
Malfunction
·GE HEALTHCARE INFORMATION TECHNOLOGIES·Product code MMH·August 8, 2008
ULTRA LABORATORY INFORMATION SYSTEM
FDA Adverse Event
Malfunction
·GE HEALTHCARE INFORMATION TECHNOLOGIES·Product code MMH·July 11, 2008
ULTRA LABORATORY INFORMATION SYSTEM
FDA Adverse Event
Malfunction
·GE HEALTHCARE INFORMATION TECHNOLOGIES·Product code MMH·July 11, 2008
ULTRA LABORATORY INFORMATION SYSTEM
FDA Adverse Event
Malfunction
·GE HEALTHCARE INFORMATION TECHNOLOGIES·Product code MMH·July 11, 2008
GE Healthcare CIC Pro" Software Versions 5.0.3, 5.0.6 ,5.0.7, 5.0.8 and 4.1. The CIC Pro" Clinical Information Center Central Station is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. The CIC Pro Central Station is intended to collect information from a network and display this data. This data included physiological, patient demographic and/or other non-medical information. Physiological parameters and waveforms from GE Healthcare Information Technologies monitors and telemetry systems can be displayed and printed from the CIC Pro Clinical Information central station. Beat to beat patient information for all parameters and waveforms from he bedsides and telemetry systems can be displayed. The CIC Pro Clinical Information Center central station supports the ability to access information from GE Medical Systems Information Technologies products in web browser format. Additionally, the CICC Pro clinical Information central station supports the ability to access patient information collected from the unity network and stored on a network server.
FDA Recall
Terminated
·GE Medical Systems Information Tecnology
9900 Inovation Drive
RP 2122 3rd Floor
Wauwatosa WI 53226·Product code DSI·February 27, 2009
GE Medical Systems Information Technologies Clinical Information Center (CIC) Pro v5.0.3 & v5.0.6 systems, GE Healthcare, Clinical Systems
FDA Recall
Terminated
·General Electric Medical Systems Information Technology·Product code DSI·November 8, 2007
OPTIMA
FDA Adverse Event
Death
·GE HANGWEI MEDICAL SYSTEMS CO., LTD.·Product code OWB·January 28, 2026
GE Medical Systems SCS
Authorized representative
🇫🇷 France·27 Manufacturers·564 Devices
The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity Enterprise Web is an image and information distribution system for the clinical review of medical images and reports. The Centricity Enterprise Web is not intended for primary diagnosis. The Centricity Enterprise Web is available as a supplemental sub-system to Centricity PACS or as a stand alone Web-based image and information distribution system. The Centricity Enterprise Web provides both the server software and a client application, which utilizes off the shelf browser technology. Centricity Enterprise Web supports several interface protocols which allows the system to be integrated with any image or information systems such as a hospital information system (HIS), radiology information system (RIS), or electronic medical record (EMR), which supports one of the supported integration protocols.
FDA Enforcement
Class II
·Terminated·Ge Healthcare It·December 11, 2013
GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. (CIC Pro v4.1). GE Medical Systems Information Technologies, Inc., Milwaukee, Wisconsin (System hardware consists of a processing unit and a monitor)
FDA Recall
Terminated
·General Electric Medical Systems Information Technology·Product code DSI·January 24, 2007
GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. , GE Medical Systems Information Technologies, Inc., 8200 W. Tower Ave. Milwaukee, Wisconsin USA. (System hardware consists of a processing unit and a monitor)
FDA Recall
Terminated
·General Electric Medical Systems Information Technology·Product code DSI·January 24, 2007
GE TELEMETRY MONITORING SYSTEM
FDA Adverse Event
Death
·GE HEALTHCARE / GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES·Product code MHX·January 26, 2026
GE HEALTHCARE TECHNOLOGY CSCS V3
FDA Adverse Event
Malfunction
·GE HEALTHCARE TECHNOLOGY / GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.·Product code DSI·December 5, 2023
GE HEALTHCARE TECHNOLOGY CSCS V3
FDA Adverse Event
Malfunction
·GE HEALTHCARE TECHNOLOGY / GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.·Product code DSI·December 5, 2023
GE HEALTHCARE TECHNOLOGY CSCS V3
FDA Adverse Event
Malfunction
·GE HEALTHCARE TECHNOLOGY / GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.·Product code DSI·December 5, 2023
GE HEALTHCARE TECHNOLOGY CSCS V3
FDA Adverse Event
Malfunction
·GE HEALTHCARE TECHNOLOGY / GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.·Product code DSI·December 5, 2023
REVOLUTION
FDA Adverse Event
Injury
·GE HANGWEI MEDICAL SYSTEMS CO., LTD.·Product code JAK·April 20, 2026
GE HEALTHCARE FINDLAND OY E-SCAIO ANASTHESIA GAS MODULE
FDA Adverse Event
Injury
·GE HEALTHCARE / GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.·Product code CCK·May 6, 2024
SERIES T2100-ST2 TREADMILL
FDA Adverse Event
Malfunction
·GE HEALTHCARE/ GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.·Product code IOL·October 5, 2023
PROTEUS
FDA Adverse Event
Injury
·GE HANGWEI MEDICAL SYSTEMS CO., LTD.·Product code KPR·April 9, 2026