Recall archive / FDA device enforcement
Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS) — FDA record Z-1625-2023
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 Apr 12, 2023. 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
- Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)
- Reason
- Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required
- Classification
- Class II
- Recalling firm
- PHILIPS HEADQUARTERS CAMBRIDGE
- Quantity
- 5 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1625-2023
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 | UDI-DI: (01)00884838103474(21) Serial Number: 530537 554032 554060 554065 554078 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
AR, CA, OK, TX Foreign: Country Argentina Australia Austria China Colombia Czech Republic Dominican Rep France Germany Guadeloupe Hong Kong India Japan Kuwait Latvia Lithuania Netherlands Norway Portugal Romania Spain Switzerland Taiwan Thailand United Kingdom Vietnam
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- May 31, 2023
- Recall initiation date
- Apr 12, 2023
- Center classification date
- May 23, 2023
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.