Philips Incisive CT with software V4 — Class II medical device recall Z-2988-2026
Ongoing recall by Philips Healthcare (Suzhou) Co., Ltd., reported 2026-09-02, distributed nationwide. Potential of failing to trigger clinical scan during Bolus Tracking.
| Recall number | Z-2988-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Philips Healthcare (Suzhou) Co., Ltd., Suzhou, N/A, China |
| Recall initiated | 2026-06-26 |
| Classified | 2026-08-21 |
| Reported by FDA | 2026-09-02 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00884838085015, 00884838105508 |
Product
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Reason for recall
Potential of failing to trigger clinical scan during Bolus Tracking.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2988-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.