Recall archive / FDA device enforcement
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334; — FDA record Z-1324-2025
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 Feb 28, 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
- Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
- Reason
- Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.
- Classification
- Class II
- Recalling firm
- Philips Medical Systems Nederland B.V.
- Quantity
- 1 unit
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1324-2025
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 | Software Version Number 5.1.0; Model number: 728334; UDI-DI: (01)00884838103627(21)1005; Serial Number (SN): 1005; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic: MN
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
- Mar 19, 2025
- Recall initiation date
- Feb 28, 2025
- Center classification date
- Mar 12, 2025
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.