12 results
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49ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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iSite PACS (Picture Archiving and Communication System), software versions 3.6.28.x and 4.1.x. The product is an image management system (software package) used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Device is intended for use by trained professionals.
FDA Recall
Terminated
·Philips Healthcare Informatics, Inc.·Product code LLZ·August 29, 2008
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 IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
FDA Enforcement
Class II
·Terminated·Philips Healthcare Informatics, Inc.·August 27, 2014
Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a computer system that assist radiology services in the storing, manipulating and retrieving of patient information. This included patient scheduling and tracking and workflow and reporting management.
FDA Enforcement
Class II
·Terminated·Philips Healthcare Informatics, Inc.·May 28, 2014
iSite PACS image management system; Picture Archiving and Communications System; Radiology software package, Philips Healthcare Informatics, Foster City, CA 94404.
FDA Recall
Terminated
·Philips Healthcare Informatics, Inc.·Product code LLZ·January 4, 2008
iSite PACS (Picture Archiving and Communications System) Versions 4.1.x up to and including 4.1.51.3, manufactured by Philips Healthcare Informatics, Foster City, CA. Device is an image management system intended to be used by trained professionals, and 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
FDA Recall
Terminated
·Philips Healthcare Informatics, Inc.·Product code LLZ·December 29, 2008
Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 4.1.17.0 - Radiology Image management system.
FDA Recall
Terminated
·Philips Healthcare Informatics, Inc.·Product code LLZ·January 29, 2008
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 Recall
Terminated
·Philips Healthcare Informatics, Inc.·Product code LLZ·October 14, 2013
Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a computer system that assist radiology services in the storing, manipulating and retrieving of patient information. This included patient scheduling and tracking and workflow and reporting management.
FDA Recall
Terminated
·Philips Healthcare Informatics, Inc.·Product code OUG·May 5, 2014
Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
FDA Recall
Terminated
·Philips Healthcare Informatics, Inc.·Product code LLZ·July 24, 2014
Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 3.6.28.0 - Radiology Image management system.
FDA Recall
Terminated
·Philips Healthcare Informatics, Inc.·Product code LLZ·January 29, 2008
Philips Healthcare Informatics iSite PACS (Picture Archiving and Communications System), version 3.5.x 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 imaging, measurement, communication and storage.
FDA Recall
Terminated
·Philips Healthcare Informatics, Inc.·Product code LLZ·July 3, 2008