Azurion IGTS Fixed Systems
FDA device recall Z-0229-2024 · posted 2024-09-30 · Open, Classified
Recall details
- Recalling firm
- Philips North America
- Reason for recall
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- OWB
- Distribution
- United States Territories of Puerto Rico, Guam, and Virgin Islands
- Date initiated
- 2023-10-04
- Date posted
- 2024-09-30
- Location
- Cambridge, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Azurion R2.1 (K200917) | Philips Medical Systems Nederland B.V. | 2020-05-01 |