Philips Healthcare (Suzhou) Co., Ltd. FDA Record
Philips Healthcare (Suzhou) Co., Ltd. has 4 FDA recalls, 3 inspections, 17 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Philips Healthcare (Suzhou) Co., Ltd., the most recent on Feb 15, 2024.
- Latest recall
- Z-2988-2026 · Class II · Jun 26, 2026
- Latest inspection
- Oct 26, 2023 · OAI
- Latest 510(k)
- Mar 23, 2026
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 4 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 17 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 3 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 1 | 0 |
| 2025 | 0 | 0 | 0 | 1 | 0 |
| 2024 | 0 | 0 | 1 | 0 | 0 |
| 2023 | 1 | 1 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 1 | 0 |
| 2021 | 0 | 0 | 0 | 1 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Philips Healthcare (Suzhou) Co., Ltd. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Feb 15, 2024 · Record page |
Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2988-2026 | Class II | Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144. | Jun 26, 2026 |
| Z-1003-2026 | Class II | Philips Incisive CT | Dec 3, 2025 |
| Z-0640-2024 | Class II | Incisive CT, model 728143 & 728144 running Software Version 5.0.0. | Dec 23, 2022 |
| Z-1273-2021 | Class II | Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide… | Feb 24, 2021 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Oct 26, 2023 | Suzhou, China | Devices | Official Action Indicated (OAI) | 3009529630 |
| Jan 10, 2019 | Suzhou, China | Devices | No Action Indicated (NAI) | 3009529630 |
| Jul 13, 2016 | Suzhou, China | Devices | No Action Indicated (NAI) | 3009529630 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Philips Healthcare (Suzhou) Co., Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3009529630 | Suzhou, China | 3 | Oct 26, 2023 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K252992 | CT Rembra RT; CT Areta RT; CT Rembra | Mar 23, 2026 |
| K260519 | Smart Fit TorsoCardiac 1.5T | Mar 20, 2026 |
| K242329 | CT Collaboration Live | Nov 18, 2024 |
| K232491 | CT 5300 | May 3, 2024 |
| K233600 | Smart Fit Knee 3.0T | Feb 5, 2024 |
| K232021 | Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T | Sep 1, 2023 |
| K223311 | Philips CT 3500 | Dec 22, 2022 |
| K212441 | Philips Incisive CT | Apr 27, 2022 |
| K212864 | dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T | Dec 1, 2021 |
| K211168 | Philips Incisive CT on Trailer | Nov 22, 2021 |
| K203514 | Precise Position | Jun 17, 2021 |
| K201640 | DuraDiagnost | Jul 9, 2020 |
| K191136 | Access CT | Jul 29, 2019 |
| K173507 | Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 | Jun 15, 2018 |
| K180015 | Philips Incisive CT | Mar 20, 2018 |
| K163410 | DigitalDiagnost C50 | Jan 4, 2017 |
| K141381 | DURADIAGNOST | Jun 12, 2014 |
Philips Healthcare (Suzhou) Co., Ltd. and the FDA: common questions
Has Philips Healthcare (Suzhou) Co., Ltd. received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Philips Healthcare (Suzhou) Co., Ltd.. The most recent is dated Feb 15, 2024.
Has Philips Healthcare (Suzhou) Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Philips Healthcare (Suzhou) Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Philips Healthcare (Suzhou) Co., Ltd.?
The most recent FDA inspection on file ended Oct 26, 2023 at Suzhou, China and was classified OAI. FDA has 3 inspections of Philips Healthcare (Suzhou) Co., Ltd. on file, 1 of them classified OAI (official action indicated).
Has Philips Healthcare (Suzhou) Co., Ltd. had an FDA recall?
Yes. Philips Healthcare (Suzhou) Co., Ltd. has 4 FDA recalls on record. The most recent started Jun 26, 2026.
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