Recall Z-0224-2024 ยท OWB Interventional Fluoroscopic X-Ray System
Philips North America
BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.
| Date | Sep 30, 2024 (initiated Oct 4, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Distribution | United States Territories of Puerto Rico, Guam, and Virgin Islands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010435 | PHILIPS BV PULSERA/ENDURA Philips Medical Systems, Inc., Mar 12, 2001 |