Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Philips. FDA records under 10 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Philips Healthcare with 61 device recalls, 44 510(k) clearances and 7 AI-enabled devices. The most recent is a device recall dated Jun 26, 2026: Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144..
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 26, 2026 | Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.Class II · Potential of failing to trigger clinical scan during Bolus Tracking. | Device recalls |
| Mar 23, 2026 | CT Rembra RT; CT Areta RT; CT RembraK252992 · JAK | 510(k) clearances |
| Mar 23, 2026 | CT Rembra RT; CT Areta RT; CT RembraK252992 · Radiology | AI-enabled devices |
| Mar 20, 2026 | Smart Fit TorsoCardiac 1.5TK260519 · MOS | 510(k) clearances |
| Dec 3, 2025 | Philips Incisive CTClass II · Potential for incomplete scan due to unstable connection inside of floating sensor. | Device recalls |
| Nov 18, 2024 | CT Collaboration LiveK242329 · LLZ | 510(k) clearances |
| May 3, 2024 | CT 5300K232491 · JAK | 510(k) clearances |
| May 3, 2024 | CT 5300K232491 · Radiology | AI-enabled devices |
| Feb 5, 2024 | Smart Fit Knee 3.0TK233600 · MOS | 510(k) clearances |
| Sep 1, 2023 | Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5TK232021 · MOS | 510(k) clearances |
| Dec 23, 2022 | Incisive CT, model 728143 & 728144 running Software Version 5.0.0.Class II · Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orie | Device recalls |
| Dec 22, 2022 | Philips CT 3500K223311 · JAK | 510(k) clearances |
| Dec 22, 2022 | Philips CT 3500K223311 · Radiology | AI-enabled devices |
| Apr 27, 2022 | Philips Incisive CTK212441 · JAK | 510(k) clearances |
| Apr 27, 2022 | Philips Incisive CTK212441 · Radiology | AI-enabled devices |
| Jun 17, 2021 | Precise PositionK203514 · Radiology | AI-enabled devices |
| Feb 24, 2021 | Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) appliClass II · Philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result in the cou | Device recalls |
| Jun 3, 2020 | QLAB Advanced Quantification SoftwareK200974 · Radiology | AI-enabled devices |
| Dec 20, 2019 | QLAB Advanced Quantification SoftwareK191647 · Radiology | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
