11 results
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7ms
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Sources: EU EUDAMED, US FDA
LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging
FDA Enforcement
Class II
·Terminated·89 NORTH·September 2, 2020
Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative measurement of lactate dehydrogenase in human serum and plasma on the Dimension Vista¿ System.Cat. No. K2054, Mat. No. 10464323
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·December 5, 2018
Pathfast D-Dimer, Reference number: PF1051-KUS
FDA Enforcement
Class II
·Terminated·Lsi Medience Corporation·November 30, 2016
Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X
FDA Enforcement
Class II
·Ongoing·Philips North America·April 3, 2024
Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 22, 2024
Patient Information Center iX; Software Version Number: 4.5.0
FDA Enforcement
Class II
·Ongoing·Philips North America·January 28, 2026
Change Healthcare Cardiology Hemodynamics software
FDA Enforcement
Class II
·Ongoing·A L I Technologies Ltd·January 22, 2025
Change Healthcare Cardiology Hemo software
FDA Enforcement
Class II
·Ongoing·A L I Technologies Ltd·January 22, 2025
McKesson Cardiology Hemo software
FDA Enforcement
Class II
·Ongoing·A L I Technologies Ltd·January 22, 2025
Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1
FDA Enforcement
Class II
·Ongoing·Philips North America·October 16, 2024
CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X
FDA Enforcement
Class II
·Ongoing·Philips North America·April 3, 2024