Philips Healthcare (Suzhou) Co., Ltd.: FDA recalls
FDA enforcement reports name Philips Healthcare (Suzhou) Co., Ltd. as the recalling firm in 4 events. The events have 4 product records. The recalls started from 2021 to 2026. All the events are device recalls.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Enforcement events
4 events, newest first.
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 26 Jun 2026 | Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144. | Device | Class II | 1 | Ongoing |
| 3 Dec 2025 | Philips Incisive CT | Device | Class II | 1 | Ongoing |
| 23 Dec 2022 | Incisive CT, model 728143 & 728144 running Software Version 5.0.0. | Device | Class II | 1 | Ongoing |
| 24 Feb 2021 | Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) applications - Product Usage: intended for use in the head and whole body. | Device | Class II | 1 | Terminated |
An event with 1 product record and a class that is not Class I has no page. It has a row in this table.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Recalling firm: The firm that the FDA record names for a recall.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Type and class
| Type | Events |
|---|---|
| Device | 4 |
| Class | Events |
|---|---|
| Class II | 4 |
- Share of the events of the firm in Class I
- 0%
- Share of all events on the register in Class I
- 18%
- Events with the status Ongoing
- 3
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Events by year
Official channels
- FDA enforcement reportsThe FDA search of the weekly enforcement reports.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA: report a problemThe FDA page that shows where a report about a product goes.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Cite this page
Recall Register. Philips Healthcare (Suzhou) Co., Ltd.: FDA recalls. https://recallregister.com/firm/philips-healthcare-suzhou-co-ltd/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- State of the firm address
- N/A
The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.
A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.
Questions
- Which classes do the FDA recalls of Philips Healthcare (Suzhou) Co., Ltd. have?
- Class II: 4 events. The class is for the product of a recall. It is not a class of the firm.
- What is the newest FDA recall of Philips Healthcare (Suzhou) Co., Ltd.?
- FDA event 99511, which the firm started on 26 Jun 2026. The first product in the record is:
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
- How many FDA recalls of Philips Healthcare (Suzhou) Co., Ltd. have the status Ongoing?
- 3 events have the status Ongoing in the openFDA file. openFDA says about the status:
FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.