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Philips Healthcare (Suzhou) Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
15
Inspections
2
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1003-2026Class IIPhilips Incisive CTDecember 3, 2025
Z-0640-2024Class IIIncisive CT, model 728143 & 728144 running Software Version 5.0.0.December 23, 2022
Z-1273-2021Class IIPhilips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide February 24, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K242329CT Collaboration LiveNovember 18, 2024
K232491CT 5300May 3, 2024
K233600Smart Fit Knee 3.0TFebruary 5, 2024
K232021Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5TSeptember 1, 2023
K223311Philips CT 3500December 22, 2022
K212441Philips Incisive CTApril 27, 2022
K212864dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5TDecember 1, 2021
K211168Philips Incisive CT on TrailerNovember 22, 2021
K203514Precise PositionJune 17, 2021
K201640DuraDiagnostJuly 9, 2020
K191136Access CTJuly 29, 2019
K173507Prodiva 1.5T CX and Prodiva 1.5T CS R5.4June 15, 2018
K180015Philips Incisive CTMarch 20, 2018
K163410DigitalDiagnost C50January 4, 2017
K141381DURADIAGNOSTJune 12, 2014