FDA Device recall Z-2988-2026
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144
- FDA Device
- Class II
- ongoing
- Published 2026-09-02
On 2026-09-02 the FDA classified a Class II recall of Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144 by Philips Healthcare Suzhou, citing potential of failing to trigger clinical scan during Bolus Tracking.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2988-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-26 |
| Published | 2026-09-02 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Philips Healthcare Suzhou |
| Distribution | US |
Product
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Reason
Potential of failing to trigger clinical scan during Bolus Tracking.
Identifiers
| code_info | Device Identifier: (01)00884838085015, (01)00884838105508. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2988-2026%22
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