FDA establishment 3009529630, Suzhou, China. Part of Philips Healthcare's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
FY2018 to FY2027 to date; 1 classified OAI
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 26, 2023 | Devices · Radiation Control and Health Safety ActDevices · Postmarket Assurance: Devices; Devices · Compliance: Devices | None posted | Official Action Indicated (OAI) |
| Jan 10, 2019 | Devices · Postmarket Assurance: DevicesDevices · Radiation Control and Health Safety Act | None posted | No Action Indicated (NAI) |
| Jul 13, 2016 | Devices · Compliance: Devices | None posted | No Action Indicated (NAI) |
| Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.Device · Z-2988-2026 | Class II | Jun 26, 2026 |
| Philips Incisive CTDevice · Z-1003-2026 | Class II | Dec 3, 2025 |
| Incisive CT, model 728143 & 728144 running Software Version 5.0.0.Device · Z-0640-2024 | Class II | Dec 23, 2022 |
| Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of…Device · Z-1273-2021 | Class II | Feb 24, 2021 |
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard, warning letters and enforcement reports
Suzhou, China. Part of