Philips North America Allura Xper IGTS Fixed Systems Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Allura Xper IGTS Fixed Systems
Brand
Philips North America
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Philips North America is recalling Allura Xper IGTS Fixed Systems due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
The following details were not provided by the FDA: corrective action details.
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026