Suzhou, CN · 12 510(k) clearances · 3 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | Class II | Radiology | 6 | 2026-03-23 |
| MOS | Coil, Magnetic Resonance, Specialty | Class II | Radiology | 4 | 2026-03-20 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 1 | 2024-11-18 |
| KPR | System, X-Ray, Stationary | Class II | Radiology | 1 | 2020-07-09 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-12-03 | Class II | Ongoing | Z-1003-2026 | Philips Incisive CT | — | Potential for incomplete scan due to unstable connection inside of floating sensor. |
| 2022-12-23 | Class II | Ongoing | Z-0640-2024 | Incisive CT, model 728143 & 728144 running Software Version 5.0.0. | — | Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT res… |
| 2021-02-24 | Class II | Terminated | Z-1273-2021 | Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed to… | — | Philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result in the couch failure to self-lock, and unexpectedl… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-03-23 | K252992 | CT Rembra RT; CT Areta RT; CT Rembra | JAK | Class II | Radiology |
| 2026-03-20 | K260519 | Smart Fit TorsoCardiac 1.5T | MOS | Class II | Radiology |
| 2024-11-18 | K242329 | CT Collaboration Live | LLZ | Class II | Radiology |
| 2024-05-03 | K232491 | CT 5300 | JAK | Class II | Radiology |
| 2024-02-05 | K233600 | Smart Fit Knee 3.0T | MOS | Class II | Radiology |
| 2023-09-01 | K232021 | Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T | MOS | Class II | Radiology |
| 2022-12-22 | K223311 | Philips CT 3500 | JAK | Class II | Radiology |
| 2022-04-27 | K212441 | Philips Incisive CT | JAK | Class II | Radiology |
| 2021-12-01 | K212864 | dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T | MOS | Class II | Radiology |
| 2021-11-22 | K211168 | Philips Incisive CT on Trailer | JAK | Class II | Radiology |
| 2021-06-17 | K203514 | Precise Position | JAK | Class II | Radiology |
| 2020-07-09 | K201640 | DuraDiagnost | KPR | Class II | Radiology |