Veradius Unity Mobile Surgery C-arm
FDA device recall Z-0230-2024 · 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
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VERADIUS UNITY (K142708) | Philips Medical Systems Nethrlands BV | 2014-10-22 |