Recall archive / FDA device enforcement
Philips Incisive CT — FDA record Z-1003-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 3, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Philips Incisive CT
- Reason
- Potential for incomplete scan due to unstable connection inside of floating sensor.
- Classification
- Class II
- Recalling firm
- Philips Healthcare (Suzhou) Co., Ltd.
- Quantity
- 35
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1003-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Not supplied |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S. and U.S. territories
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jan 14, 2026
- Recall initiation date
- Dec 3, 2025
- Center classification date
- Jan 8, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.