147 results
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27ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277, VS2+ 863278, 863279. The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility. The SureSigns VSi vital signs monitor is for measurement of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility
FDA Enforcement
Class II
·Terminated·Philips Healthcare Inc.·September 5, 2012
Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns VS4 vital signs monitor is for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 monitor is for monitoring, recording, and alarming of multiple physiological parameters in healthcare environments for the patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.
FDA Enforcement
Class II
·Ongoing·Philips Electronics North America Corporation·August 29, 2018
Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed tomography (CT) x-ray systems or sub-systems, each with a continuously rotating x-ray tube and multi-row detectors enclosed by a gantry. X-ray transmission data acquired and taken at different angles can be reconstructed into cross-sectional images. Each device also includes signal analysis and display equipment, patient and equipment supports, components, and accessories.
FDA Enforcement
Class II
·Terminated·Philips Healthcare Inc.·April 24, 2013
Philips SureSigns VS2 monitor, 863079 863080 863081 863082 863283 863286 The Sure Signs VS2 vital signs monitor is for use by healthcare professionals whenever there is a need for monitoring the physiological parameter of patients. Standard and optional parameters include: NBP, Sp02, Temperature. The Sure Signs VS2 vital signs monitor is for the monitoring, recording and alarming of multiple parameters of adult, pediatric and neonates in healthcare environments. Additionally, this monitor is intended for transport situations within the healthcare facility.
FDA Enforcement
Class II
·Ongoing·Philips Electronics North America Corporation·August 29, 2018
Philips Healthcare DuraDiagnost X- Ray
FDA Enforcement
Class II
·Terminated·Philips Medical Systems, Inc.·May 27, 2015
Philips Healthcare DigitalDiagnost System X-Ray
FDA Enforcement
Class II
·Terminated·Philips Medical Systems, Inc.·May 27, 2015
Philips SureSigns VS3 Vital Signs Monitor, 863069 863070 863071 863072 863073 863074 The SureSigns VS3 monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.
FDA Enforcement
Class II
·Ongoing·Philips Electronics North America Corporation·August 29, 2018
Philips Healthcare DuraDiagnost stationary X-ray system
FDA Enforcement
Class II
·Terminated·Philips Healthcare·June 15, 2016
Philips Healthcare DigitalDiagnost stationary X-ray system
FDA Enforcement
Class II
·Terminated·Philips Healthcare·June 15, 2016
Philips Healthcare System X-ray Tomography Computed :
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·November 30, 2016
Philips Healthcare System X-ray Tomography Computed :
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·November 30, 2016
Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
FDA Enforcement
Class II
·Terminated·Philips Medical Systems, Inc.·October 15, 2014
Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics, Inc. Foster City, CA IntelliSpace PACS are image management systems intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RE, RT, MG, SC, VL, as well as hospital/radiology information systems.
FDA Enforcement
Class II
·Terminated·Philips Healthcare Informatics, Inc.·November 20, 2013
Philips Healthcare Ingenuity Core Computed Tomography X-ray system
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·December 23, 2015
Philips Healthcare Ingenuity CT Computed Tomography X-ray system
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·December 23, 2015
Philips Healthcare Brilliance 64 Computed Tomography X-Ray System
FDA Enforcement
Class II
·Terminated·Philips Healthcare·June 15, 2016
Philips Healthcare Ingenuity CT Computed Tomography X-Ray System
FDA Enforcement
Class II
·Terminated·Philips Healthcare·June 15, 2016
Philips Healthcare Brilliance iCT Computed Tomography X-Ray System
FDA Enforcement
Class II
·Terminated·Philips Healthcare·June 15, 2016
Philips Healthcare Ingenuity Core Computed Tomography X-Ray System
FDA Enforcement
Class II
·Terminated·Philips Healthcare·June 15, 2016
Philips Healthcare IntelliVue Info Center iX, A.0 866023
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·March 2, 2016