Philips Healthcare

FDA Regulatory Profile

Summary

Total Recalls
57
510(k) Clearances
1
Inspections
3
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2520-2023Class IIIncisive CT, software version 5.0August 2, 2023
Z-0737-2022Class IIPhilips StentBoost Live R2.0 application, when used with the Philips Azurion with software release February 2, 2022
Z-0238-2022Class IIPhilips Azurion systems with software releases 2.1(L1) and 2.1(L2)September 24, 2021
Z-0240-2022Class IIProxiDiagnost N90 is multi-functional general R/F systems.September 22, 2021
Z-0239-2022Class IIDigitalDiagnost C90September 22, 2021
Z-0241-2022Class IICombiDiagnost R90 is multi-functional general R/F systems.September 22, 2021
Z-0734-2022Class IIAzurion systems with software release R2.0.xMay 26, 2021
Z-2498-2019Class IIDigitalDiagnost C50, Stationary X-ray SystemDecember 21, 2018
Z-2500-2018Class IICentron Product Usage: Vascular,cardiovascular and neurovascular imaging applications,includinJune 11, 2018
Z-2498-2018Class IIAllura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,inclJune 11, 2018
Z-2499-2018Class IIUNIQ Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including dJune 11, 2018
Z-1695-2016Class IIPhilips Healthcare DigitalDiagnost stationary X-ray systemNovember 10, 2015
Z-1696-2016Class IIPhilips Healthcare DuraDiagnost stationary X-ray systemNovember 10, 2015
Z-1718-2016Class IIPhilips Healthcare Ingenuity Core128 Computed Tomography X-Ray SystemSeptember 6, 2015
Z-1713-2016Class IIPhilips Healthcare Brilliance 64 Computed Tomography X-Ray SystemSeptember 6, 2015
Z-1717-2016Class IIPhilips Healthcare Ingenuity CT Computed Tomography X-Ray SystemSeptember 6, 2015
Z-1715-2016Class IIPhilips Healthcare Brilliance iCT SP Computed Tomography X-Ray SystemSeptember 6, 2015
Z-1719-2016Class IIPhilips Healthcare Ingenuity Elite Computed Tomography X-Ray SystemSeptember 6, 2015
Z-1716-2016Class IIPhilips Healthcare Ingenuity Core Computed Tomography X-Ray SystemSeptember 6, 2015
Z-1714-2016Class IIPhilips Healthcare Brilliance iCT Computed Tomography X-Ray SystemSeptember 6, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K152899Philips Lumify Diagnostic Ultrasound SystemOctober 30, 2015