Drug recall
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
FDA recall event 99511 · Class II · Philips Healthcare (Suzhou) Co., Ltd.
Key facts
| Event ID | 99511 |
|---|---|
| Recall numbers | Z-2988-2026 |
| Recalling firm | Philips Healthcare (Suzhou) Co., Ltd. |
| Product type | Devices |
| Products | Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA Requested |
| Reason for recall | Potential of failing to trigger clinical scan during Bolus Tracking. |
| Initiation date | Jun 26, 2026 |
| Report date | Sep 2, 2026 |
| City | Suzhou |
| Country | China |
| FEI number | 3009529630 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: