FDA DevicesClass II
Philips Incisive CT
Published: January 14, 2026Recall ID: Z-1003-2026Category: devicesCountry: US
Reason for Recall / Hazard
Potential for incomplete scan due to unstable connection inside of floating sensor.
Product Description & Identification
Philips Incisive CT
Additional Source Details
| Field | Value |
|---|---|
| City | Suzhou |
| Event id | 98238 |
| Address 1 | Suzhou Industrial Park |
| Address 2 | No. 258 Zhongyuan Road; Pingjiang |
| Postal code | N/A |
| Report date | 20260114 |
| Product type | Devices |
| Product quantity | 35 |
| Reason for recall | Potential for incomplete scan due to unstable connection inside of floating sensor. |
| Voluntary mandated | FDA Mandated |
| Recall initiation date | 20251203 |
| Center classification date | 20260108 |
Overview
- Recalling FirmPhilips Healthcare (Suzhou) Co., Ltd.
- StatusOngoing
- Risk LevelClass II
- DistributionU.S. and U.S. territories