7 results
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6ms
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Sources: EU EUDAMED, US FDA
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - Brilliance iCT SP
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
Brilliance iCT; Product Code (REF): 728306;
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·February 18, 2026
Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 1, 2025
Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 1, 2025
Alinity ci-series System Control Module, REF: 03R70-01
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·January 3, 2024
Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c Processing Module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c Processing Module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes).
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·January 17, 2024
Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·September 22, 2021