Allura Xper IGTS Fixed Systems
This recall is currently active, issued September 30, 2024. It was issued by Philips North America.
- Company
- Philips North America
- Recall Initiated
- October 4, 2023
- Posted
- September 30, 2024
- Recall Number
- Z-0228-2024
- Firm Location
- Cambridge, MA
- Official Source
- View on FDA website ↗
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.
Distribution
United States Territories of Puerto Rico, Guam, and Virgin Islands
Lot / Code Info
Allura Xper FD10 285 Allura Xper FD10 1517 Allura Xper FD10 1634 Allura Xper FD10 177 Allura Xper FD10 764 ALLURA Xper FD10 C 249 Allura Xper FD20 2013 Allura Xper FD20 1334 Allura Xper FD20 1473 Allura Xper FD20 2110 Allura Xper FD20 2155 Allura Xper FD20 919 Allura Xper FD20 1581 Allura Xper FD20 2353 Allura Xper FD20 1811 Allura Xper FD20 2087 Allura Xper FD20 53364 Allura Xper FD20/15 172
Root Cause
Device Design