5 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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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 (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; Software Version Number: 4.5.0
FDA Enforcement
Class II
·Ongoing·Philips North America·January 28, 2026
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
Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product Description: Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio is an in vitro diagnostic (IVD) test that combines the test results of the Lumipulse G pTau 217 Plasma assay and the Lumipulse G ¿-Amyloid 1-42-N Plasma assay from the same patient specimen (K2EDTA plasma sample) into a numerical ratio. The Lumipulse G pTau 217/¿-Amyloid 1-42 Plasma Ratio Instructions For Use (IFU), CL0072, contains instructions on how to manually calculate the ratio and is supplied with each individual Lumipulse G assay. Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio, Item# CL0073 is comprised of the following kits, which are imported: Kit Description, Item#: Imported from Fujirebio Europe (FRE): Lumipulse G pTau 217 Plasma Immunoreaction Cartridges 81550 Lumipulse G pTau 217 Plasma Calibrators set 81557 Lumipulse pTau 217 Plasma Controls 81558 Lumipulse ¿-Amyloid Plasma Controls 81559 Imported from Fujirebio Japan (FRI): Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges 235447 Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators set 235454 Component: No
FDA Enforcement
Class II
·Ongoing·Fujirebio Diagnostics, Inc.·February 11, 2026