Recall archive / FDA device enforcement
Integris-Allura IGTS Fixed Systems — FDA record Z-0227-2024
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 Oct 4, 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
- Integris-Allura IGTS Fixed Systems
- Reason
- Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.
- Classification
- Class II
- Recalling firm
- Philips North America
- Quantity
- Not supplied
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0227-2024
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 | INTEGRIS Allura 15-12 (mono) 68 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
United States Territories of Puerto Rico, Guam, and Virgin Islands
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Nov 15, 2023
- Recall initiation date
- Oct 4, 2023
- Center classification date
- Nov 9, 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.