433 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Recall
×
ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code NBW·March 6, 2013
EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-Vitro diagnostics devices.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code NSX·June 7, 2012
Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System Accu-Chek inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings. This system should only be use with single-use, auto-disabling lancing devices.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code LFR·February 11, 2016
BD Synapsys Informatics Solution, Catalog Number 444150
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JQP·June 8, 2023
BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JQP·March 9, 2022
Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 Product Usage: The Accu-Chek Inform II test strips are for use with the Accu-Chek Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heel stick, or fresh capillary whole blood samples drawn from the fingertips as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples.
FDA Recall
Terminated
·Roche Diabetes Care, Inc.·Product code LFR·May 7, 2018
BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JQP·October 31, 2024
EasyLink Informatics System, software version 3.0, Part Number 1000034941, DADE BEHRING INC., Newark, DE.
FDA Recall
Terminated
·Dade Behring, Inc.·Product code JJE·July 3, 2007
BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code KZB·July 9, 2024
Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001
FDA Recall
Open, Classified
·Roche Diabetes Care, Inc.·Product code NBW·July 28, 2021
EasyLink Informatics Systems QCFIRST Custom Rule The EasyLink Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostic devices. The EasyLink is included with the Dimension Vista System (K051087), and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JJE·July 23, 2010
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
EasyLink(TM) Informatics Systems Software Version 5.0 and Software Version 5.0 Service Packs 1 through 4 used with the Dimension Vista(R) System. The EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostics devices. The EasyLink(TM) is included with the Dimension Vista(R) System, and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks. Product Quantity Distributed (Int) 787
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JJE·December 2, 2011
EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic device intended tot duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. The EasyLink Informatics System is classified as a data calculator and processing module for use with in vitro diagnostic devices. The EasyLink is included with the Dimension Vista System and may be used with other Siemens analyzers as a communications and connectivity workstation for integration with laboratory information system (LIS) networks.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JQP·May 29, 2012
BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JQP·September 12, 2024
IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.
FDA Recall
Completed
·Philips Healthcare Informatics, Inc.·Product code LLZ·April 19, 2019
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